JP2011062344A

JP2011062344A - Medical guide wire and method of manufacturing the same, and assembly of medical guide wire and microcatheter, or balloon catheter and guiding catheter

Info

Publication number: JP2011062344A
Application number: JP2009215559A
Authority: JP
Inventors: Tomihisa Kato; 富久加藤
Original assignee: PatentStra Co Ltd
Current assignee: PatentStra Co Ltd
Priority date: 2009-09-17
Filing date: 2009-09-17
Publication date: 2011-03-31
Anticipated expiration: 2029-09-17
Also published as: EP2298488B1; US8211039B2; US20110066106A1; JP5500924B2; EP2298488A1

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method of manufacturing a medical guide wire using a stainless steel wire as a core wire, as technologies for appropriate conditions for improving the tensile strength characteristics of the core wire by focusing on the temperature and the tension strength characteristics of the core wire subjected to a high processing wire drawing. <P>SOLUTION: The core wire is subjected to the high processing wire drawing with a whole cross sectional reduction rate as 90-97.6% by using an austenitic stainless steel wire treated with a solid solution procedure as the core wire. The mechanical strength characteristics of the core wire are improved by heat-treating the core wire at low temperature repetitively under appropriate conditions each time when the core wire is subjected to mechanical processing, and by a twisting processing under the low-temperature heat treatment, use of heat in forming a resin film for the core wire and by considering heat conductivity of the core wire, etc. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

この発明は、ステンレス鋼線から成る芯線を各機械的加工した後に、一定の温度範囲の低温熱処理を加えることにより芯線の機械的強度特性を向上させた医療用ガイドワイヤとその製造方法に関する。 The present invention relates to a medical guide wire in which the mechanical strength characteristics of the core wire are improved by subjecting the core wire made of stainless steel wire to mechanical processing, followed by low-temperature heat treatment in a certain temperature range, and a manufacturing method thereof.

血管内へ挿入する医療用ガイドワイヤは細線である為、機械的強度特性を考慮して人体への安全確保を満たさなければならず、この為種々の提案がなされている。 Since a medical guide wire inserted into a blood vessel is a thin wire, it must satisfy the safety of the human body in consideration of mechanical strength characteristics, and various proposals have been made for this purpose.

特許文献１には、高珪素ステンレス鋼（Ｓｉ：３．０％から５％）を用いて所定の加工度と低温熱処理条件等が記載され、芯線の引張強度特性向上を目的としている。 Patent Document 1 describes a predetermined degree of processing and low-temperature heat treatment conditions using high silicon stainless steel (Si: 3.0% to 5%), and aims to improve the tensile strength characteristics of the core wire.

特許文献２には、弾性形状記憶合金を用いて所定の加工条件等が記載され、品質向上を目的としている。 Patent Document 2 describes predetermined processing conditions using an elastic shape memory alloy and aims to improve quality.

特許文献３には、金属細線を用いて分割したゾーン毎に異なる捻回加工と異なる熱処理等が記載され、品質向上を目的としている。 Patent Document 3 describes a different twisting process and a different heat treatment for each zone divided using a thin metal wire, and aims to improve quality.

特開２００３−３４２６９６号公報JP 2003-342696 A 特開２０００−５１２６９１号公報JP 2000-512691 A 特開２００５−１４０４０号公報JP 2005-14040 A

従来の医療用ガイドワイヤにおいては、その芯線材料として一般的に用いられるオーステナイト系ステンレス鋼線を用いているが、医療用ガイドワイヤとしての特性を満足させる為に芯線への機械的加工を施す際、予め加工度の高い強加工の伸線加工を行い、その後芯線に機械的加工を施す際、この強加工した芯線の熱影響による引張強度特性に着目して、医療用ガイドワイヤ特有の各加工工程毎に芯線の機械的加工と低温熱処理との相関性において、芯線の引張強度特性向上効果を有する工程を累積することにより、高度の引張強度特性を有する芯線から成る医療用ガイドワイヤ、及びその製造方法に関する技術思想は存在していない。
この発明の目的は、芯線にオーステナイト系ステンレス鋼線を用いて強加工した芯線への熱影響による引張強度特性と医療用ガイドワイヤとしての特性を満たすべく、芯線に施す機械的加工との相関性において、最も好ましい芯線の引張強度特性を得て、術者が安全に操作できる医療用ガイドワイヤを提供することにある。 Conventional medical guidewires use austenitic stainless steel wire, which is generally used as the core wire material. In order to satisfy the characteristics as a medical guidewire, the core wire is mechanically processed. , When performing high-strength, high-strength wire drawing, and then mechanically processing the core wire, pay attention to the tensile strength characteristics due to the heat effect of the strongly processed core wire, and each processing unique to medical guidewires A medical guide wire composed of a core wire having a high tensile strength characteristic by accumulating steps having an effect of improving the tensile strength characteristic of the core wire in the correlation between the mechanical processing of the core wire and the low-temperature heat treatment for each process, and its There is no technical idea regarding the manufacturing method.
The object of the present invention is to correlate the tensile strength characteristics due to the heat effect on the core wire, which is strongly processed using an austenitic stainless steel wire as the core wire, and the mechanical processing applied to the core wire in order to satisfy the characteristics as a medical guide wire. It is an object of the present invention to provide a medical guide wire that can obtain the most preferable tensile strength characteristic of a core wire and can be safely operated by an operator.

請求項１記載の発明は、可とう性細長体から成る芯線と、芯線の先端部に芯線を貫挿したコイルスプリング体を装着し、芯線とコイルスプリング体との先端端部に接合部材を用いて先導栓を形成した医療用ガイドワイヤにおいて、芯線が固溶化処理したオーステナイト系ステンレス鋼線を用いて、伸線工程と伸線工程後に４００℃〜４９５℃の低温熱処理工程を設けて、伸線工程と低温熱処理工程を１セットとして少なくとも１セット以上各工程を繰り返した後に最終伸線工程を設けて、最終伸線工程までの総減面率を９０％から９７．６％とし、最終伸線工程までの低温熱処理による引張破断強度の増加率の合計が８％以上とし、最終伸線工程の後に芯線に電気抵抗加熱による低温熱処理下で所定の捻回加工を行い、その後芯線先端部に機械的加工である研削加工、又は押圧加工を経た後、芯線の外周部へ樹脂被膜成形時に加熱する熱を利用して３４０℃〜４２０℃の低温熱処理を行い、最終伸線工程後の各低温熱処理による引張破断強度の増加率の合計が２％以上とし、各低温熱処理による引張破断強度の増加率の合計が１０％以上であることを特徴とする。この構成により、強加工の伸線加工後の低温熱処理と引張強度特性、及び機械的加工後の低温熱処理と引張強度特性との相関性に着目して、各工程毎に引張強度特性向上効果を有する工程を累積させて、高度の引張強度特性を有する芯線から成る医療用ガイドワイヤを得ることができる。そして、電気抵抗加熱による低温熱処理下での芯線の捻回加工により、総減面率が９０％を超える強加工の芯線を用いても捻回数を増大させて直線性を向上させることができ、かつ捻回工程での芯線の断線を防いで安定した品質の芯線から成る医療用ガイドワイヤの提供ができる。 According to the first aspect of the present invention, a core wire made of a flexible elongated body, a coil spring body having a core wire inserted through the tip end portion of the core wire, and a joining member are used at the tip end portions of the core wire and the coil spring body. In a medical guide wire having a lead plug formed therein, an austenitic stainless steel wire whose core wire is subjected to a solid solution treatment is used, and a low temperature heat treatment step of 400 ° C. to 495 ° C. is provided after the wire drawing step. The process and low temperature heat treatment process are set as one set, and after each process is repeated at least one set, the final wire drawing process is provided, and the total area reduction until the final wire drawing process is changed from 90% to 97.6%. The total rate of increase in tensile fracture strength due to low-temperature heat treatment up to the process is 8% or more. After the final wire drawing process, the core wire is subjected to a predetermined twisting process under low-temperature heat treatment by electric resistance heating, and then the core wire tip is machined. After grinding or pressing, which is a typical process, low-temperature heat treatment at 340 ° C. to 420 ° C. is performed on the outer periphery of the core wire during the formation of the resin film, and each low-temperature heat treatment after the final wire drawing step The total increase rate of the tensile break strength due to the low temperature heat treatment is 2% or more, and the total increase rate of the tensile break strength due to each low-temperature heat treatment is 10% or more. With this configuration, paying attention to the correlation between low temperature heat treatment and tensile strength characteristics after wire drawing of strong processing, and low temperature heat treatment and tensile strength characteristics after mechanical processing, the effect of improving tensile strength characteristics for each process By accumulating the steps, a medical guide wire made of a core wire having a high tensile strength characteristic can be obtained. And, by twisting the core wire under low-temperature heat treatment by electric resistance heating, the number of twists can be increased and the linearity can be improved even when using a strongly processed core wire with a total area reduction rate exceeding 90%, In addition, it is possible to provide a medical guide wire made of a core wire of stable quality by preventing the core wire from being disconnected in the twisting process.

請求項２記載の発明は、請求項1 記載の発明に対して、最終伸線工程の後に芯線に所定量の捻回加工を行い、その捻回加工の捻回数の増大に伴って前記芯線に電気抵抗加熱により徐変昇温させて３８０℃〜４９５℃を最高温度とする低温熱処理下での捻回加工としたことを特徴とする。
この構成により、総減面率が９０％から９７．６％の加工度の高い芯線を用いて捻回加工をする際に捻回数の増大に伴って結晶粒の、より微細化がすすみ、かつ、増大する残留応力を徐変昇温により除去することとなり、そして芯線の表層部と内層部の不均質を極めて少なくして均質化させ、前記同様引張破断強度が高く、直線性が向上し、さらに捻回加工工程での断線を防いで安定した品質の芯線から成る医療用ガイドワイヤの提供ができる。 The invention according to claim 2 is the same as that of claim 1, wherein a predetermined amount of twisting is performed on the core wire after the final wire drawing step, and the core wire is subjected to an increase in the number of twists in the twisting processing. It is characterized by a twisting process under a low-temperature heat treatment in which the temperature is gradually changed by electric resistance heating and the maximum temperature is 380 ° C to 495 ° C.
With this configuration, when twisting is performed using a core wire having a high degree of processing with a total area reduction of 90% to 97.6%, the crystal grains are further refined as the number of twists increases, and , The increasing residual stress will be removed by gradually changing the temperature, and the surface layer portion and the inner layer portion of the core wire will be homogenized with very little homogeneity, as described above, the tensile strength at break is high, and the linearity is improved, Furthermore, it is possible to provide a medical guide wire made of a core wire with stable quality by preventing disconnection in the twisting process.

請求項３記載の発明は、請求項１〜２のいずれか一つに記載の発明に対して、芯線先端部の機械的加工後に、芯線の外周部に樹脂被膜成形前に一定の温度範囲に制御した低温熱処理を施したことを特徴とし、この構成により引張破断強度の増加率の合計を１１．５％以上向上させることができる。 The invention according to claim 3 is the same as the invention according to any one of claims 1 to 2, after the mechanical processing of the core wire tip portion, within a certain temperature range before the resin film molding on the outer peripheral portion of the core wire. A controlled low-temperature heat treatment is performed, and this configuration can improve the total increase rate of tensile breaking strength by 11.5% or more.

請求項４記載の発明は、請求項１〜３のいずれか一つに記載の発明の芯線を用いて、芯線先端部の研削加工部分の低温熱処理後に押圧加工を行ない、少なくとも押圧加工した部分に芯線先端部に装着されたコイルスプリング体外周部の樹脂被膜成形時の熱を利用して、一定の温度範囲に制御した低温熱処理を行い、押圧加工部分の引張強度特性を向上させることができる。 The invention according to claim 4 uses the core wire according to any one of claims 1 to 3 to perform press processing after the low-temperature heat treatment of the ground portion of the core wire tip, and at least to the pressed portion Using the heat at the time of resin film molding of the outer periphery of the coil spring body attached to the tip of the core wire, low-temperature heat treatment controlled to a certain temperature range can be performed, and the tensile strength characteristics of the pressed portion can be improved.

請求項５記載の発明は、請求項１〜４のいずれか一つに記載の発明に対して、総減面率を９４％から９７．６％として、芯線の引張破断強度を大幅に向上させることができる。この構成により、電気抵抗加熱による低温熱処理下で芯線に捻回加工を加えたものと、捻回加工を加えないで低温熱処理したものと比較して、引張破断強度の増加率が異なり、総減面率９４％を境にして、急激な引張破断強度が増大し、高強度の引張強度特性を有する芯線から成る医療用ガイドワイヤを得ることができる。 The invention according to claim 5 provides a significant improvement in the tensile strength at break of the core wire with respect to the invention according to any one of claims 1 to 4 by setting the total area reduction rate from 94% to 97.6%. be able to. With this configuration, the rate of increase in tensile fracture strength differs between the case where the core wire was twisted under low temperature heat treatment by electric resistance heating and the case where the core wire was heat treated at low temperature without twisting, and the total decrease A medical guide wire composed of a core wire having a high tensile strength characteristic can be obtained with an abrupt increase in tensile strength at an area ratio of 94%.

請求項６記載の発明は、可とう性細長体から成る芯線と、芯線の先端部に芯線を貫挿したコイルスプリング体を装着し、芯線とコイルスプリング体との先端端部に接合部材を用いて先導栓を形成した医療用ガイドワイヤにおいて、芯線が固溶化処理したオーステナイト系ステンレス鋼線を用いて、伸線工程と伸線工程の後に４００℃〜４９５℃で１０分から１８０分の低温熱処理工程を設けて、伸線工程と低温熱処理工程を１セットとして少なくとも１セット以上各工程を繰り返した後に最終伸線工程を設けて、最終伸線工程までの総減面率を９０％から９７．６％とし、その後芯線に電気抵抗加熱による３８０℃〜４９５℃で３０秒から６０分の低温熱処理下で、芯線の一端に捻回加工前の芯線の引張破断力の５％から３０％の負荷荷重を加えた状態で、他端を１００回／ｍから２７５回／ｍの捻回加工工程を設け、その後芯線先端部を研削加工、又は研削加工後に押圧加工する工程と、芯線の先端部に芯線を貫挿してコイルスプリング体を装着する工程と、接合部材を用いて芯線とコイルスプリング体とを部分的に接合させる工程と、接合部材を用いて芯線とコイルスプリング体の端部とを接合させた先導栓を形成する工程から成ることを特徴とする医療用ガイドワイヤの製造方法である。
この構成により、強加工伸線後の低温熱処理と、強加工の捻回加工時の低温熱処理により、各強加工工程での残留応力を除去し、引張強度特性の高い芯線から成る医療用ガイドワイヤを得ることができる。 In the invention described in claim 6, a core wire made of a flexible elongated body, a coil spring body having a core wire inserted through the tip end portion of the core wire, and a joining member are used at the tip end portions of the core wire and the coil spring body. In a medical guide wire having a lead plug, a low temperature heat treatment process at 400 to 495 ° C. for 10 minutes to 180 minutes after the wire drawing process and the wire drawing process using an austenitic stainless steel wire whose core wire is solid solution treated The wire drawing step and the low-temperature heat treatment step are set as one set, and after at least one set is repeated, the final wire drawing step is provided, and the total area reduction until the final wire drawing step is 90% to 97.6. After that, under a low temperature heat treatment at 380 ° C. to 495 ° C. for 30 seconds to 60 minutes by electrical resistance heating on the core wire, a load of 5% to 30% of the tensile breaking force of the core wire before twisting is applied to one end of the core wire The In this state, the other end is provided with a twisting process of 100 times / m to 275 times / m, and then the core wire tip is ground or pressed after grinding, and the core wire is passed through the tip of the core wire. A step of inserting and attaching the coil spring body, a step of partially joining the core wire and the coil spring body using the joining member, and a lead joint joining the core wire and the end of the coil spring body using the joining member A medical guide wire manufacturing method comprising a step of forming a stopper.
With this configuration, a medical guide wire consisting of a core wire with high tensile strength characteristics by removing residual stress in each strong working process by low temperature heat treatment after strong work drawing and low temperature heat treatment at the time of strong work twisting Can be obtained.

請求項７記載の発明は、請求項６記載の発明に対して、電気抵抗加熱による低温熱処理下での強加工の捻回加工後に、一定温度範囲（４００℃〜４９５℃）の低温熱処理工程を設けることにより、又請求項８記載の発明は、請求項６記載の発明に対して芯線先端部研削加工後に、芯線の樹脂被膜成形時の熱を利用して芯線に一定温度範囲（３４０℃〜４２０℃）に制御した低温熱処理工程を設けることにより、前記同様引張強度特性の高い芯線から成る医療用ガイドワイヤの製造方法である。 The invention according to claim 7 is the same as the invention according to claim 6 except that a low-temperature heat treatment step in a certain temperature range (400 ° C. to 495 ° C.) is performed after the twisting of strong processing under low-temperature heat treatment by electric resistance heating. By providing, the invention according to claim 8 is directed to the core wire in a certain temperature range (340 ° C. to 340 ° C.) using the heat at the time of the resin coating forming of the core wire after the core wire tip grinding process. By providing a low-temperature heat treatment process controlled at 420 ° C., the medical guide wire is made of a core wire having high tensile strength characteristics as described above.

請求項９記載の発明は、請求項６〜８のいずれか一つに記載の発明に対して、前記最終伸線工程後に、芯線に所定量の捻回加工を行ない、捻回数の増大に伴って芯線に電気抵抗加熱により徐変昇温させて３８０℃〜４９５℃を最高温度とする低温熱処理下での捻回加工工程としたことを特徴とする。
この構成により、捻回数の増大に伴って結晶粒の、より微細化がすすみ、かつ、増大する残留応力を徐変昇温により徐変除去することにより、芯線の表層部と内層部の不均質を極めて少なくして均質化させて、前記同様引張破断強度が高く、直線性が向上し、さらに捻回加工工程での断線を防いで安定した品質の芯線から成る医療用ガイドワイヤの製造方法の提供ができる。 The invention according to claim 9 is the invention according to any one of claims 6 to 8, wherein a predetermined amount of twisting is performed on the core wire after the final wire drawing step, and the number of twists is increased. The core wire is subjected to a twisting process under low-temperature heat treatment where the temperature is gradually changed by electric resistance heating and the maximum temperature is 380 ° C to 495 ° C.
With this configuration, the crystal grains become finer as the number of twists increases, and the residual stress that increases is gradually removed by gradually increasing the temperature. A method for producing a medical guide wire comprising a core wire of stable quality with high tensile breaking strength, high linearity, and prevention of breakage in the twisting process as described above. Can be provided.

請求項１０記載の発明は、請求項６〜９のいずれか一つに記載の発明に対して、芯線の他端の捻回数が１００回／ｍから２００回／ｍの捻回加工工程としたことを特徴とする。この構成により、芯線の表層部と内層部との不均質を極めて少なくして均質化させ、曲げ変形後の残留角度を極めて少なくして、直線性向上、および安定した品質の芯線から成る医療用ガイドワイヤの製造方法の提供ができる。 The invention described in claim 10 is a twisting process in which the number of twists at the other end of the core wire is 100 times / m to 200 times / m, compared to the invention according to any one of claims 6-9. It is characterized by that. With this configuration, the inhomogeneity between the surface layer portion and the inner layer portion of the core wire is extremely reduced and homogenized, the residual angle after bending deformation is extremely reduced, the linearity is improved, and the medical wire comprising the core wire with stable quality A method for manufacturing a guide wire can be provided.

請求項１１記載の発明は、請求項６〜１０のいずれか一つに記載の発明に対して、接合部材を用いて芯線とコイルスプリング体とを接合させた後に、コイルスプリング体外周部の樹脂被膜成形時の熱を利用して、少なくともコイルスプリング体内の芯線に一定温度範囲（１８０℃〜３００℃）に制御した低温熱処理工程を設けることにより、前記同様引張強度特性の高い芯線から成る医療用ガイドワイヤの製造方法である。 The invention according to claim 11 is the resin according to any one of claims 6 to 10, wherein the core wire and the coil spring body are joined using the joining member, and then the resin on the outer periphery of the coil spring body. By using the heat at the time of film forming, at least the core wire in the coil spring body is provided with a low-temperature heat treatment process controlled within a certain temperature range (180 ° C. to 300 ° C.), so that the medical wire consisting of a core wire having high tensile strength characteristics as described above. It is a manufacturing method of a guide wire.

請求項１２記載の発明は、接合部材が１８０℃〜４９５℃の溶融温度をもつ共晶合金から成る請求項１〜５のいずれかの医療用ガイドワイヤで、請求項１３記載の発明は、前記接合部材から成る請求項６〜１１のいずれかの医療用ガイドワイヤの製造方法である。
この構成により、芯線とコイルスプリング体とを接合部材を用いて接合する際、接合時の熱による芯線の引張破断強度を低下させることなく、むしろこの接合部材の溶融熱を利用して芯線の引張破断強度を向上させ、芯線と中間固定部材の接合部、及び芯線と先導栓の接合部での芯線の引張破断強度を向上させる接合を可能とすることができる。 The invention according to claim 12 is the medical guide wire according to any one of claims 1 to 5, wherein the joining member is made of a eutectic alloy having a melting temperature of 180 ° C to 495 ° C. It is a manufacturing method of the medical guide wire in any one of Claims 6-11 which consists of a joining member.
With this configuration, when the core wire and the coil spring body are joined using the joining member, the tensile strength of the core wire is utilized by utilizing the heat of fusion of the joining member without decreasing the tensile breaking strength of the core wire due to heat during joining. Breaking strength can be improved, and joining that improves the tensile breaking strength of the core wire at the joint portion between the core wire and the intermediate fixing member and at the joint portion between the core wire and the leading plug can be made possible.

請求項１４記載の発明は、請求項１〜５、１２のいずれか一つに記載の医療用ガイドワイヤと、マイクロカテーテルと、ガイディングカテーテルとの組立体において、医療用ガイドワイヤの外径が０．２２８ｍｍから０．２５４ｍｍ（０．００９インチから０．０１０インチ）で、医療用ガイドワイヤを内径が０．２８ｍｍから０．９０ｍｍのマイクロカテーテル内へ挿入し、かつ、内径が１．５９ｍｍから２．００ｍｍのガイディングカテーテル内へ、医療用ガイドワイヤとマイクロカテーテルが挿入されていることを特徴とする医療用ガイドワイヤとマイクロカテーテルとガイディングカテーテルとの組立体である。この構成により、細径化された組立体を得ることができる。 According to a fourteenth aspect of the present invention, in the assembly of the medical guidewire, the microcatheter and the guiding catheter according to any one of the first to fifth and twelfth aspects, the outer diameter of the medical guidewire is 0.228 mm to 0.254 mm (0.009 inch to 0.010 inch) medical guide wire inserted into a microcatheter having an inner diameter of 0.28 mm to 0.90 mm and an inner diameter of 1.59 mm A medical guide wire, a microcatheter, and a guiding catheter assembly, wherein a medical guide wire and a microcatheter are inserted into a 2.00 mm guiding catheter. With this configuration, an assembly with a reduced diameter can be obtained.

請求項１５記載の発明は、請求項１〜５、１２のいずれか一つに記載の医療用ガイドワイヤと、バルーンカテーテルと、ガイディングカテーテルとの組立体において、医療用ガイドワイヤの外径が０．２２８ｍｍから０．２５４ｍｍ（０．００９インチから０．０１０インチ）で、医療用ガイドワイヤを内径が０．２８ｍｍから０．９０ｍｍのバルーンカテーテル内へ挿入し、かつ、内径が１．５９ｍｍから２．００ｍｍのガイディングカテーテル内へ、医療用ガイドワイヤとバルーンカテーテルが挿入されていることを特徴とする医療用ガイドワイヤとバルーンカテーテルとガイディングカテーテルとの組立体である。この構成により、細径化された組立体を得ることができる。 According to a fifteenth aspect of the present invention, in the assembly of the medical guidewire, the balloon catheter, and the guiding catheter according to any one of the first to fifth and twelfth aspects, the outer diameter of the medical guidewire is 0.228 mm to 0.254 mm (0.009 inch to 0.010 inch) medical guide wire inserted into a balloon catheter having an inner diameter of 0.28 mm to 0.90 mm and an inner diameter of 1.59 mm A medical guide wire, balloon catheter, and guiding catheter assembly, wherein a medical guide wire and a balloon catheter are inserted into a 2.00 mm guiding catheter. With this configuration, an assembly with a reduced diameter can be obtained.

医療用ガイドワイヤと芯線の正面図、及び芯線の要部拡大図である。It is the front view of a medical guide wire and a core wire, and the principal part enlarged view of a core wire. 低温熱処理と引張強度特性図（実施例１、２）Low temperature heat treatment and tensile strength characteristics (Examples 1 and 2) 低温熱処理と引張強度特性図（実施例６、７、８）Low temperature heat treatment and tensile strength characteristics (Examples 6, 7 and 8) 低温熱処理と引張強度特性図（実施例１、２、６、７、８）Low temperature heat treatment and tensile strength characteristics (Examples 1, 2, 6, 7, 8) 低温熱処理有無の捻回回数と引張強度特性図Number of twists and tensile strength characteristics with and without low-temperature heat treatment 低温熱処理有無の捻回回数と曲げ残留角度の特性図Characteristic diagram of number of twists and residual bending angle with and without low-temperature heat 電気抵抗加熱による連続捻回製造方法の実施形態Embodiment of continuous twist manufacturing method by electric resistance heating 温度と引張強度特性図Temperature and tensile strength characteristics 総減面率と引張強度特性図Total area reduction and tensile strength characteristics 医療用ガイドワイヤの他の実施例の正面図、側面図である。It is the front view of the other Example of a medical guide wire, and a side view.

この発明の最良の実施形態を図に示すとともに説明する。 The best embodiment of the present invention will be described with reference to the drawings.

図１は実施例の医療用ガイドワイヤ１を示し、芯線２の先端部２１には、同軸的に外嵌めされたコイルスプリング体（以下コイル体）３を有し、コイル体３の先端側には金、白金、タングステン等の放射線不透過材コイル３１から成り、その芯線２の先端部２１には、中間前側接合部材４１、中間後側接合部材４２、後端接合部材４３により、芯線２とコイル体３とが接合部材を用いて部分的にそれぞれ接合され、又芯線２の先端端部に先丸形状の円柱状の先導栓５が接合部材４により形成されて芯線２とコイル体３とを接合している。 FIG. 1 shows a medical guide wire 1 according to an embodiment. A distal end portion 21 of a core wire 2 has a coil spring body (hereinafter referred to as a coil body) 3 that is coaxially fitted on the distal end side of the coil body 3. Consists of a radiopaque material coil 31 such as gold, platinum, tungsten or the like, and the core wire 2 is connected to the front end portion 21 of the core wire 2 by an intermediate front side joining member 41, an intermediate rear side joining member 42, and a rear end joining member 43. The coil body 3 is partially joined to each other by using a joining member, and a rounded cylindrical lead plug 5 is formed at the tip end portion of the core wire 2 by the joining member 4 so that the core wire 2 and the coil body 3 Are joined.

そして芯線２は、先端部２１の先端から約３００ｍｍは、概ね０．０６０ｍｍから０．２００ｍｍの細径の線で、残りの手元部２２は、約１２００ｍｍから約２７００ｍｍで太径の線から成っている。先端部２１の細径部分は、先端側へ徐変縮径し、その断面形状は円形断面、又は矩形断面いずれの形状であってもよい。又、芯線２の手元側２２の外周部にフッ素樹脂、ウレタン樹脂等の樹脂被膜６が形成され、特にコイル体３の外周部にはウレタン樹脂等、芯線２の手元側２２の外周部にはフッ素樹脂（ＰＴＦＥ）が被膜成形されている。
そしてその外周部には、湿潤時に潤滑特性を示すポリビニルピロリドン等の親水性被膜７が形成され、芯線２の先端部２１は、前記樹脂被膜等により密閉状に包被されている。 The core wire 2 is a thin wire having a diameter of approximately 0.060 mm to 0.200 mm, approximately 300 mm from the tip of the tip portion 21, and the remaining proximal portion 22 is formed of a thick wire having a diameter of approximately 1200 mm to approximately 2700 mm. Yes. The small-diameter portion of the distal end portion 21 gradually changes in diameter toward the distal end, and the cross-sectional shape thereof may be either a circular cross section or a rectangular cross section. In addition, a resin coating 6 such as a fluororesin or a urethane resin is formed on the outer peripheral portion of the core wire 2 on the proximal side 22, and particularly on the outer peripheral portion of the coil body 3 on the proximal side 22 of the core wire 2. A fluororesin (PTFE) is formed into a film.
And the outer peripheral part is formed with a hydrophilic film 7 such as polyvinyl pyrrolidone which exhibits lubricating properties when wet, and the tip part 21 of the core wire 2 is hermetically covered with the resin film or the like.

そして芯線２は、固溶化処理したオーステナイト系ステンレス鋼線を用いて、総減面率が９０％から９７．６％の伸線加工を行ったことを特徴とする。尚、ここでいう総減面率とは、固溶化処理した線材の線径と伸線加工により伸線工程での最終仕上がり線径との間の断面積差を減少率で表したものをいう。
そして総減面率が９０％以上としたのは、８０％を境にして引張破断強度が増大し、９０％以上で急傾斜増大するからである。（図９）これは、９０％以上という強加工の伸線加工により加工度の増大に伴い繊維状組織となり、この組織の発達によるものと考えられる。そして総減面率が９７．６％以下としたのは、これを超える強い加工度では、組織内に空隙が生じはじめて脆化し、これが伸線加工の限界と考えるからである。 And the core wire 2 is characterized by performing wire drawing with a total area reduction of 90% to 97.6% using a solution-treated austenitic stainless steel wire. Here, the total area reduction ratio means a reduction ratio indicating a difference in cross-sectional area between the wire diameter of the solid solution processed wire and the final finished wire diameter in the wire drawing process. .
The reason why the total area reduction is 90% or more is that the tensile fracture strength increases at 80% and the steep slope increases at 90% or more. (FIG. 9) This is considered to be due to the development of this structure as it becomes a fibrous structure as the degree of processing increases due to the strong wire drawing of 90% or more. The reason why the total area reduction is 97.6% or less is that when the degree of processing exceeds this, voids begin to form in the structure and become brittle, which is considered the limit of wire drawing.

そして「固溶化処理したオーステナイト系ステンレス鋼線の伸線加工」としたのは、加工性のよいオーステナイト組織を得る為であり、オーステナイト系ステンレス鋼線は変態点を利用した熱処理による結晶粒の微細化ができず、冷間加工によってのみ結晶粒の微細化が可能で、伸線加工により顕著な加工硬化性を示して引張強度特性を向上させることができるからである。又オーステナイト系ステンレス鋼線を用いる理由は、マルテンサイト系ステンレス鋼線では熱処理による焼入硬化性を示して熱影響を受け易く、又フェライト系ステンレス鋼線では温度脆性（シグマ脆性、４７５℃脆性）の問題があるからである。 The reason why “Solubilized austenitic stainless steel wire was drawn” was to obtain an austenitic structure with good workability, and the austenitic stainless steel wire was refined by heat treatment using transformation points. This is because the crystal grains can be refined only by cold working, and the tensile strength characteristics can be improved by exhibiting remarkable work hardenability by wire drawing. The reason for using austenitic stainless steel wire is that martensitic stainless steel wire exhibits quench hardenability by heat treatment and is easily affected by heat, and ferritic stainless steel wire is temperature brittle (sigma brittle, 475 ° C brittle) Because there is a problem.

ここで表1 は、固溶化処理したオーステナイト系ステンレス鋼線の引張破断強度６８ｋｇｆ／ｍｍ²の線材（母材）の線径１．５ｍｍを用いて一次伸線後、温度範囲が４００℃〜４９５℃で１０分から１８０分で熱処理炉を用いた炉内での雰囲気加熱による一次低温熱処理（本実施例では４２０℃、７５分）を行ない、その後二次伸線（本実施例で最終伸線）を行い、総減面率を９０％（実施例１）、及び９４％（実施例２）として、その後前記同様温度範囲が４００℃〜４９５℃で１０分から１８０分で熱処理炉を用いた炉内での雰囲気加熱による二次低温熱処理（本実施例では４５０℃、１２０分）を加え、そして芯線２の先端部２１を外径０．１５０ｍｍまで研削加工を行ない、その後芯線２の手元部２２に吹付け等によるＰＴＦＥ等のフッ素樹脂の塗膜成形後の乾燥・焼成の為の雰囲気による加熱を、芯線２の温度による引張強度特性を考慮して３４０℃〜４２０℃の温度範囲で１０分から１８０分の三次低温熱処理（本実施例では３８５℃、３０分）を加えたものである。そしてこの表１をグラフ化したものが図２である。尚、ここでいう引張破断強度とは、芯線に引張力を加えて破断した値を芯線の断面積で除した値のことをいう。 Table 1 shows a temperature range of 400 ° C. to 495 after primary wire drawing using a wire diameter of 1.5 mm of a wire rod (base material) having a tensile breaking strength of 68 kgf / mm ² of a solution treated austenitic stainless steel wire. First low-temperature heat treatment (at 420 ° C. for 75 minutes in this example) by atmospheric heating in a furnace using a heat treatment furnace at 10 ° C. to 180 minutes, followed by secondary wire drawing (final wire drawing in this example) In a furnace using a heat treatment furnace with a total area reduction rate of 90% (Example 1) and 94% (Example 2), and thereafter in the same temperature range from 400 ° C. to 495 ° C. for 10 minutes to 180 minutes. A secondary low-temperature heat treatment (at 450 ° C. for 120 minutes in this embodiment) is performed by heating in the atmosphere, and the tip portion 21 of the core wire 2 is ground to an outer diameter of 0.150 mm. Such as PTFE by spraying Heating in an atmosphere for drying / firing after forming a coating film of fluororesin, taking into consideration the tensile strength characteristics depending on the temperature of the core wire 2, a third low-temperature heat treatment in the temperature range of 340 ° C to 420 ° C for 10 minutes to 180 minutes (this In the examples, 385 ° C., 30 minutes) was added. FIG. 2 is a graph of Table 1. Here, the tensile breaking strength means a value obtained by dividing a value obtained by applying a tensile force to the core wire and dividing the value by the cross-sectional area of the core wire.

尚、以下において各表中における丸付き数字は、文中においてカッコ付き数字で示すものである。
表１によると、最終伸線（本実施例では二次伸線）前までの低温熱処理（本実施例では一次低温熱処理）による引張破断強度の増加率は、実施例１で１２．６％、実施例２で１３．３％となり、そして最終伸線後の各低温熱処理後の引張破断強度の増加率の合計（２）+ （３）は、実施例１、２でそれぞれ２．８％、４．０％となって、前記伸線工程を含む各低温熱処理の張破断強度の増加率の合計（１）＋（２）＋（３）は、実施例１、２でそれぞれ１５．４％、１７．３％となる。特に機械的加工した研削部分の外径が０．１５０ｍｍの芯線の引張破断強度を断面積換算すると、実施例１で研削加工前と比較して、４、５２２ｇｆが４、５７５ｇｆとなって約５３ｇｆ増大し、又同様に実施例２では、約７１ｇｆ増大する。
この研削加工した芯線２の先端部分は冠状動脈内の屈曲蛇行病変部へ侵入して操作される為、引張強度、及び繰り返し屈曲曲げ耐疲労特性が要求される部位であり、そして繰り返し耐久回数は応力の関数（Ｓ−Ｎ線図）で表わせる為、この部位の少しの増加率であっても、繰り返し耐久回数は飛躍的に増大することとなる。 In the following, circled numbers in each table are shown in parentheses in the sentence.
According to Table 1, the rate of increase in tensile rupture strength by low temperature heat treatment (primary low temperature heat treatment in this example) before final wire drawing (secondary wire drawing in this example) is 12.6% in Example 1, The total increase rate of tensile fracture strength after each low-temperature heat treatment after the final wire drawing (2) + (3) was 2.8% in Examples 1 and 2, respectively. The total increase rate (1) + (2) + (3) of the tensile breaking strength of each low-temperature heat treatment including the wire drawing step was 4.0% in Examples 1 and 2, respectively. , 17.3%. In particular, when the tensile strength at break of a core wire having an outer diameter of 0.150 mm of the mechanically machined portion is converted into a cross-sectional area, 4,522 gf is 4,575 gf in Example 1 and about 53 gf compared with before grinding. Similarly, in Example 2, it increases by about 71 gf.
Since the tip of the ground core 2 is processed by invading the bending meandering lesion in the coronary artery, the tensile strength and the repeated bending / bending fatigue resistance are required. Since it can be expressed by a function of stress (SN diagram), the number of repeated endurance increases dramatically even with a slight increase rate of this part.

そして補足すれば、一次伸線後の低温熱処理の温度範囲を４００℃〜４９５℃で１０分から１８０分としたのは、後述するオーステナイト系ステンレス鋼線の強加工伸線での温度による引張強度特性（図８）と強加工伸線工程での生産性、及び品質の安定を考慮した為であり、又最終伸線工程後の二次低温熱処理の温度範囲を４００℃〜４９５℃で１０分から１８０分としたのは、前記同様オーステナイト系ステンレス鋼線の強加工伸線での温度による引張強度特性（図８）と、熱処理炉を用いた雰囲気加熱による生産性、及び品質の安定を考慮した為であり、又研削加工後の三次低温熱処理の温度範囲を３４０℃〜４２０℃で１０分から１８０分としたのは、芯線２の少なくとも手元部２２に樹脂被膜成形するフッ素樹脂（ＰＴＦＥ）の乾燥・焼成の為の加熱温度によるオーステナイト系ステンレス鋼線の強加工伸線での温度による引張強度特性（図８）の向上効果と生産性、及び品質の安定を考慮した為である。尚、伸線工程と低温熱処理工程を１セットとして、５セット以上繰り返してもよいが、経済性、生産性等の観点から３セット以下が望ましい。
又一次伸線工程と二次伸線工程の各工程内での減面率は、いずれを高く設定してもよいが、一次低温熱処理前に一次伸線工程の減面率を高く設定（本実施例では８７．５％から９４．２％）することにより、加工誘起マルテンサイト量を多くして、熱処理による結晶粒成長を抑制し、結晶粒径を小さくすることができる。そして又、経済性、生産性等の観点から一次伸線工程での減面率を高く設定し、その後の伸線工程をそれより低く設定することが望ましい。又、加工誘起マルテンサイト生成による引張破断強度向上効果をより高める為、伸線時の芯線表面温度である加工温度は、１４０℃以下が望ましく、湿式伸線での冷却液の設定、又は伸線時ダイスへシャワー状に吹き付ける潤滑剤の設定、及びこれらの温度設定等によりこれを達成できる。 And supplementally, the reason why the temperature range of the low-temperature heat treatment after the primary wire drawing is from 400 ° C. to 495 ° C. from 10 minutes to 180 minutes is that the tensile strength characteristics depending on the temperature at the high-work drawing of austenitic stainless steel wire described later (FIG. 8) and the stability in the high-strength wire drawing process and the stability of the quality are taken into consideration, and the temperature range of the secondary low-temperature heat treatment after the final wire drawing process is 400 ° C to 495 ° C from 10 minutes to 180 minutes. In consideration of the tensile strength characteristics with temperature (Fig. 8) in the high-strength wire drawing of austenitic stainless steel wire, productivity by atmospheric heating using a heat treatment furnace, and quality stability, as described above. The reason why the temperature range of the third low-temperature heat treatment after grinding is 10 minutes to 180 minutes at 340 ° C. to 420 ° C. is that the fluororesin (PTFE) that forms a resin film on at least the hand portion 22 of the core wire 2 is dried. - improvement and productivity in temperature due to the tensile strength properties of the strong working drawing austenitic stainless steel wire by the heating temperature for the calcination (FIG. 8), and is because in consideration of the stability of quality. In addition, although a wire drawing process and a low-temperature heat treatment process are made into 1 set and 5 sets or more may be repeated, 3 sets or less are desirable from viewpoints of economy, productivity, etc.
In addition, the area reduction rate in each step of the primary wire drawing process and the secondary wire drawing process may be set high, but the area reduction rate in the primary wire drawing process is set high before the primary low temperature heat treatment (this (In the example, 87.5% to 94.2%) By increasing the amount of work-induced martensite, crystal grain growth due to heat treatment can be suppressed, and the crystal grain size can be reduced. Moreover, it is desirable to set the area reduction rate in the primary wire drawing process high from the viewpoints of economy and productivity, and to set the subsequent wire drawing process lower than that. In addition, in order to further enhance the effect of improving the tensile fracture strength due to the formation of work-induced martensite, the processing temperature, which is the core wire surface temperature at the time of wire drawing, is desirably 140 ° C. or less, and the setting of the cooling liquid in wet wire drawing or wire drawing This can be achieved by setting the lubricant to be sprayed on the die at the time and setting these temperatures.

次に、表２は前記実施例１、２に対して、総減面率が９４．８％（実施例３）、９６％（実施例４）、９７．６％（実施例５）の伸線加工を行ない、そして最終伸線工程後（本実施例では二次伸線）の芯線２に電気抵抗加熱による３８０℃〜４９５℃（約１．８アンペア）の温度範囲で３０秒から６０分（本実施例では４５０℃、５分）低温熱処理下で一定条件による捻回加工を加え、そして前記同様芯線２の先端部２１に研削加工等の機械的加工を行い、その後温度範囲を３４０℃〜４２０℃で１０分から１８０分の電気抵抗加熱以外の熱処理炉等を用いた雰囲気加熱による低温熱処理工程（本実施例では３８５℃、３０分）後の引張強度特性を示したものである。上記以外の低温熱処理については、実施例１、２と同様である。尚、芯線の捻回は、後述する負荷荷重（ウエイト１２）を加えた状態で捻回加工を行い、その負荷荷重は捻回加工前の芯線の引張破断力の１０％から３０％（本実施例では２０％）であり、以後実施例６〜８、１１〜１３も同様である。 Next, Table 2 shows that the total area reduction is 94.8% (Example 3), 96% (Example 4), and 97.6% (Example 5) with respect to Examples 1 and 2 above. After the final wire drawing process (secondary wire drawing in this embodiment), the core wire 2 is subjected to electric resistance heating at a temperature range of 380 ° C. to 495 ° C. (about 1.8 amperes) for 30 seconds to 60 minutes. (In this embodiment, 450 ° C., 5 minutes) Twist processing under a certain condition is performed under low-temperature heat treatment, and mechanical processing such as grinding is performed on the tip portion 21 of the core wire 2, and then the temperature range is 340 ° C. It shows the tensile strength characteristics after a low temperature heat treatment step (385 ° C., 30 minutes in this example) by atmospheric heating using a heat treatment furnace other than electric resistance heating at ˜420 ° C. for 10 minutes to 180 minutes. The low-temperature heat treatment other than the above is the same as in Examples 1 and 2. In addition, the twisting of the core wire is performed by adding a load (weight 12) described later, and the load is 10% to 30% of the tensile breaking force of the core wire before the twisting (this implementation) 20% in the example), and the same applies to Examples 6-8 and 11-13.

表２によると、最終伸線（本実施例では二次伸線）前までの一次低温熱処理による引張破断強度の増加率は、実施例３、４、５でそれぞれ１２．５％、１３．３％、１２．６％となり、そして最終伸線後の各低温熱処理の引張破断強度の増加率の合計（２）＋（３）は、実施例３、４、５でそれぞれ５．１％、７．９％、７．６％となって前記伸線工程を含む各低温熱処理の引張破断強度の増加率の合計（１）＋（２）＋（３）は、実施例３、４、５でそれぞれ１７．６％、２１．２％、２０．２％となる。特に、電気抵抗加熱下での捻回加工を施すと、その引張破断強度の増加率は、前記実施例１、２よりも高い傾向を示す。（図３） According to Table 2, the rate of increase in tensile fracture strength by the primary low-temperature heat treatment before the final wire drawing (secondary wire drawing in this example) is 12.5% and 13.3 in Examples 3, 4 and 5, respectively. %, 12.6%, and the total increase rate (2) + (3) of the tensile fracture strength of each low-temperature heat treatment after the final wire drawing was 5.1%, 7 for Examples 3, 4 and 5, respectively. The total increase rate (1) + (2) + (3) of the tensile breaking strength of each low-temperature heat treatment including the wire drawing step is 0.9% and 7.6% in Examples 3, 4, and 5. These are 17.6%, 21.2%, and 20.2%, respectively. In particular, when twisting is performed under electric resistance heating, the rate of increase in tensile fracture strength tends to be higher than in Examples 1 and 2. (Figure 3)

この理由は、芯線２の長軸方向の強加工の伸線加工に加え、さらに長軸傾斜方向に捻回の強加工を加えたことにより強加工伸線による芯線２の表層部と内層部の不均質性、例えば内層部は硬度が低く、表層部近くは硬度が高い不均質性を一定限度に均質化して、局部的に発生している残留応力の除去によるもの、と考えることができる。 The reason for this is that, in addition to the strong wire drawing process in the major axis direction of the core wire 2 and the twisting strong work in the major axis inclined direction, the surface layer portion and the inner layer portion of the core wire 2 by the strong work drawing wire It can be considered that the inhomogeneity, for example, the inner layer portion has a low hardness and the near-layer portion has a high hardness is homogenized to a certain limit to remove the residual stress generated locally.

そして補足すれば、電気抵抗加熱の低温熱処理条件として３８０℃〜４９５℃の温度範囲としたのは、後述するオーステナイト系ステンレス鋼線の強加工伸線による温度の引張強度特性（図８）と後述する捻回加工した芯線２の曲げ試験後の曲げ変形残留角度（図６）を考慮した為であり、低温加熱時間を３０秒から６０分以内としたのは、３０秒を下回れば引張強度特性向上効果は少なく、又６０分を超えれば一定値となり、若しくは、顕著な前記向上効果は得られないからである。 As a supplementary explanation, the temperature range of 380 ° C. to 495 ° C. was set as the low temperature heat treatment condition for electric resistance heating. The tensile strength characteristics of the temperature due to the strong work drawing of the austenitic stainless steel wire described later (FIG. 8) and the following This is because the bending deformation residual angle (Fig. 6) after the bending test of the twisted core wire 2 is taken into consideration. The reason for setting the low temperature heating time within 30 to 60 minutes is that the tensile strength characteristics are reduced if the time is less than 30 seconds. This is because the improvement effect is small, and if it exceeds 60 minutes, it becomes a constant value, or the remarkable improvement effect cannot be obtained.

次に、表３は前記実施例３、４、５に対して、前記同様芯線に電気抵抗加熱による低温熱処理下で一定条件による捻回加工後に、温度範囲を４００℃〜４９５℃で１０分から１８０分の、熱処理炉等を用いた雰囲気加熱による二次低温熱処理（本実施例では４５０℃、１２０分）を行ない、芯線２の先端部２１の研削加工後は、前記実施例１〜５と同様である。そして、その表３をグラフ化したものが図３である。尚、表３のうち実施例６、７、８は前記実施例３、４、５にそれぞれ対応する。 Next, Table 3 shows that, for the examples 3, 4 and 5, the core wire was twisted under certain conditions under low temperature heat treatment by electric resistance heating, and the temperature range was 400 ° C. to 495 ° C. for 10 minutes to 180 minutes. The second low-temperature heat treatment (at 450 ° C. for 120 minutes in this embodiment) by atmospheric heating using a heat treatment furnace or the like is performed, and after the grinding of the tip portion 21 of the core wire 2, the same as in the first to fifth embodiments. It is. FIG. 3 is a graph of Table 3. In Table 3, Examples 6, 7, and 8 correspond to Examples 3, 4, and 5, respectively.

表３によると最終伸線（本実施例では二次伸線）前までの低温処理による引張破断強度の増加率は、前記実施例３〜５と同様であり、そして最終伸線後の各低温熱処理の引張破断強度の増加率の合計（２）＋（３）＋（４）は、実施例６、７、８でそれぞれ６．４％、９．１６％、９．１％となって前記伸線工程を含む各低温熱処理の引張破断強度の増加率の合計（１）＋（２）＋（３）＋（４）は、実施例６、７、８でそれぞれ１８．９％、２２．５％、２１．７％となり、本実施例の中でいずれも高い値となる。
この理由は、芯線２の長軸方向の強加工伸線と長軸傾斜方向に捻回の強加工を加えたことにより、前記芯線２の表層部と内層部の硬度分布等の不均質性を一定限度に均質化できることと、そしてさらに後述するオーステナイト系ステンレス鋼線の強加工伸線による温度の引張破断強度特性を把握して、好適な温度と時間を加えることにより、芯線２の表層部と内層部の不均質を極めて少なくして、より均質化させ、そして局部的に発生した残留応力除去によるもの、と考えることができる。尚、補足すれば、電気抵抗加熱の低温熱処理条件として温度範囲が３８０℃〜４９５℃で３０秒から６０分としたのは、前記実施例３、４、５と同様の理由による。 According to Table 3, the rate of increase in tensile fracture strength by the low temperature treatment before the final wire drawing (secondary wire drawing in this example) is the same as in Examples 3 to 5, and each low temperature after the final wire drawing. The total increase rate (2) + (3) + (4) of the tensile fracture strength of the heat treatment was 6.4%, 9.16%, and 9.1% in Examples 6, 7, and 8, respectively. The total increase rate (1) + (2) + (3) + (4) of the tensile fracture strength of each low-temperature heat treatment including the wire drawing step is 18.9% and 22.2 in Examples 6, 7, and 8, respectively. 5% and 21.7%, which are both high values in this embodiment.
The reason for this is that by adding a strong work drawing in the major axis direction of the core wire 2 and a strong work of twisting in the major axis tilt direction, the hardness distribution and the like of the surface layer portion and the inner layer portion of the core wire 2 are reduced. The surface layer of the core wire 2 can be homogenized to a certain limit, and by grasping the tensile breaking strength characteristics of the austenitic stainless steel wire, which will be described later, due to the strong work drawing, and adding a suitable temperature and time, It can be considered that the inhomogeneity of the inner layer portion is extremely reduced to make the inner layer portion more uniform and to remove the residual stress generated locally. In addition, for supplementary reasons, the reason why the temperature range of 380 ° C. to 495 ° C. is set to 30 seconds to 60 minutes as the low temperature heat treatment conditions for electric resistance heating is the same as in Examples 3, 4, and 5.

次に図４は、図２と図３を合成させた図である。これから電気抵抗加熱による低温熱処理下で捻回加工した後に低温熱処理を施したほうが捻回加工をしないものに低温熱処理を施したものと比較して、引張破断強度の増加率が高く、又総減面率９４％近傍を境にして、引張破断強度の急激な増加傾向がみられる。 Next, FIG. 4 is a diagram in which FIGS. 2 and 3 are combined. From now on, the rate of increase in tensile fracture strength is higher when the low-temperature heat treatment is performed after the low-temperature heat treatment by electrical resistance heating, compared to the case where the low-temperature heat treatment is applied to the non-twisted one, and the total decrease A sharp increase in the tensile strength at break is observed at an area ratio of 94%.

そして、本発明での電気抵抗加熱による３８０℃〜４９５℃の低温熱処理下での捻回加工とは、芯線に通電させて３８０℃〜４９５℃に到達した後に前記温度の低温熱処理下で芯線の捻回加工を行いながら、捻回加工による残留応力除去を施してもよく、又好ましくは冷間状態、つまり室温状態から芯線の捻回を開始して捻回数の増大に伴って３８０℃〜４９５℃を最高温度とする徐変昇温による低温熱処理であり、本実施例ではこれを用いた。
そして、捻回の開始と同時、又はその前後に芯線に通電を開始して、所定量の捻回数の到達前、又は到達後に電気抵抗加熱による前記最高温度に到達させるいずれの場合も含まれる。所定量の捻回数の到達前に前記最高温度に到達させる場合は、捻回時の断線の発生を抑制する効果が高く、芯線の総減面率が９０％を超えて比較的高い値の場合（例えば９４％から９７．６％）に好適であり、又その一方、所定量の捻回数の到達後に前記最高温度に到達させる場合には、前記芯線の総減面率が９０％以上の比較的低い値の場合（例えば９０％から９４％未満）に好適であり、いずれを選択するかは、要求される芯線に引張破断強度特性、外周研削加工性、及び曲げ残留角度等の各特性により任意選択する。 And the twisting process under low temperature heat treatment of 380 ° C. to 495 ° C. by electric resistance heating in the present invention means that after the core wire is energized to reach 380 ° C. to 495 ° C., the core wire is subjected to low temperature heat treatment at the above temperature. While performing the twisting process, the residual stress may be removed by the twisting process. Preferably, twisting of the core wire is started from the cold state, that is, the room temperature state, and the number of twists is increased to 380 ° C. to 495. This is a low-temperature heat treatment by gradual temperature increase with a maximum temperature of ° C., and this was used in this example.
In addition, any case where the core wire is energized at the same time as the start of the twisting or before and after the start of the twisting to reach the maximum temperature by electric resistance heating before or after reaching the predetermined number of twists is included. When reaching the maximum temperature before reaching the predetermined number of times of twisting, the effect of suppressing the occurrence of disconnection during twisting is high, and the total area reduction of the core wire exceeds 90% and is a relatively high value (For example, from 94% to 97.6%) On the other hand, when reaching the maximum temperature after reaching a predetermined number of twists, the total area reduction rate of the core wire is 90% or more. This value is suitable for a low value (for example, from 90% to less than 94%), and which one is selected depends on the required characteristics such as tensile breaking strength characteristics, peripheral grinding workability, and bending residual angle. Optional.

そしてこの方法を用いる理由は、芯線２に用いるオーステナイト系ステンレス鋼線は、加工度の増大に伴って機械的強度は増大し、特に総減面率が９０％から９７．６％に伸線加工した芯線は加工度が高く、さらに冷間状態で捻回加工を行なうことにより結晶粒の微細化をより促進させて機械的強度をさらに増大させることができる。特に、総減面率が９４％以上の芯線を用いて捻回加工すると、芯線の表層部と内層部の硬度分布の不均質が著しくなり、引張破断強度の高い芯線は得られるものの、捻回途中で芯線の断線が頻発するようになる。
そして、これを防ぐ為、捻回数の増大に伴って熱処理温度を所定温度まで徐変昇温させる方法を用いると、捻回数の増大に伴う結晶粒のより微細化、及び局部的に増大発生する残留応力を、徐変昇温とすることにより捻回数の増大に伴って増大する残留応力を徐変除去することとなる。そして芯線の表層部と内層部の硬度分布の不均質性を一定範囲に均質化させて局部的に発生した残留応力除去をより促進させることができ、その結果、引張破断強度が高く、直線性が向上し、かつ後述する曲げ試験後の曲げ残留角度の小さい芯線を得ることができ、さらに、前記強加工伸線の捻回加工時の芯線の断線を防いで、安定した品質の芯線から成る医療用ガイドワイヤの提供ができる。 The reason for using this method is that the austenitic stainless steel wire used for the core wire 2 increases in mechanical strength as the degree of work increases, and in particular, the total area reduction is 90% to 97.6%. The processed core wire has a high degree of processing, and further, by performing twisting in a cold state, it is possible to further increase the mechanical strength by further promoting the refinement of crystal grains. In particular, when twisting is performed using a core wire having a total area reduction of 94% or more, the hardness distribution of the surface layer portion and the inner layer portion of the core wire becomes extremely heterogeneous, and a core wire having high tensile fracture strength can be obtained. The core wire breaks frequently on the way.
In order to prevent this, if a method of gradually changing the temperature of the heat treatment to a predetermined temperature with an increase in the number of twists is used, the crystal grains become finer and increase locally as the number of twists increases. By making the residual stress a gradual change temperature rise, the residual stress that increases with the increase in the number of twists is gradually changed and removed. And the hardness distribution of the surface layer part and inner layer part of the core wire can be homogenized within a certain range, and the residual stress generated locally can be further promoted, resulting in high tensile breaking strength and linearity It is possible to obtain a core wire having a small bending residual angle after a bending test, which will be described later, and further comprising a core wire of stable quality by preventing disconnection of the core wire during twisting of the above-mentioned strong wire drawing. A medical guide wire can be provided.

次に表４、５は、表１、２、３のうち最終熱処理である低温熱処理（３８５℃、３０分）後に、芯線２の先端部２１の研削加工部分を板幅０．０９４ｍｍ、板厚０．０３０ｍｍの偏平状の矩形断面形状に押圧加工した後に、前記芯線２の先端部２１にコイル体３を装着後、コイル体３の外周部にポリウレタン、ポリアミド等熱可塑性樹脂を用いて押出成形、デッピング工法、樹脂収縮チューブ等の樹脂被膜成形の際に、コイル体３の外周部又はコイル体３の外周部と手元部２２に１８０℃〜３００℃で１０秒から６０分の樹脂被膜成形機の加熱利用、又は樹脂収縮チューブ加熱機の加熱利用による先端部２１と手元部２２へ低温熱処理、例えばポリウレタンであれば、２００℃、５分の低温熱処理を加えたときの引張強度特性を示したものである。尚、表４のうち実施例９、１０、１１は前記実施例１、２、６に、又表５のうち実施例１２、１３は前記実施例７、８にそれぞれ対応し、この各実施例の芯線２に押圧加工を行い、低温熱処理（２００℃、５分）を加えたものである。 Next, in Tables 4 and 5, after the low-temperature heat treatment (385 ° C., 30 minutes) which is the final heat treatment in Tables 1, 2, and 3, the ground portion of the tip portion 21 of the core wire 2 has a plate width of 0.094 mm and a plate thickness. After pressing into a flat rectangular cross-sectional shape of 0.030 mm, the coil body 3 is attached to the distal end portion 21 of the core wire 2, and then the outer periphery of the coil body 3 is extruded using a thermoplastic resin such as polyurethane or polyamide. When forming a resin film such as a dipping method or a resin shrinkable tube, a resin film forming machine is formed at 180 ° C. to 300 ° C. for 10 seconds to 60 minutes on the outer peripheral portion of the coil body 3 or the outer peripheral portion and the hand portion 22 of the coil body 3. The tensile strength characteristics were shown when low temperature heat treatment was applied to the distal end portion 21 and the proximal portion 22 by heating utilization of a resin shrinkable tube heater or, for example, polyurethane, at 200 ° C. for 5 minutes. With things That. In Table 4, Examples 9, 10, and 11 correspond to Examples 1, 2, and 6, and in Table 5, Examples 12 and 13 correspond to Examples 7 and 8, respectively. The core wire 2 is pressed and subjected to low-temperature heat treatment (200 ° C., 5 minutes).

表４、５によると、芯線２の押圧加工後にコイル体３の外周部の樹脂被膜成形時の熱を利用して、一定温度範囲の低温熱処理（本実施例では２００℃、５分）を施したものの引張破断強度の増加率は、実施例９、１０、１１でそれぞれ１．２％、１．１％、１．０％又実施例１２、１３では、共に０．６％増大させることができる。そして、押圧加工部位での芯線２の矩形断面積で換算すると、実施例９〜１１で約６．６ｇｆ上昇し、又実施例１２、１３で約４．４ｇｆ上昇させることができる。このことは、芯線２と先導栓５の引張破断力が２５０ｇｆ近傍であること、この芯線２と先導栓５の接合部位は、狭窄病変部内で術者による手操作で繰り返し曲げ耐久性が要求され、この繰り返し曲げ耐久回数は応力の関数（Ｓ−Ｎ線図）で表わされることとを併せ考えれば、少しの増加率であっても耐久性向上に寄与することができ、そして又、本発明の実施例では、雰囲気加熱による熱処理炉を用いなくても、樹脂被膜成形、又は樹脂収縮チューブの加熱利用により必要な箇所に部分的に引張破断強度を向上させる、新たな技術思想を開示するものである。 According to Tables 4 and 5, low-temperature heat treatment (200 ° C., 5 minutes in this embodiment) in a certain temperature range is performed using the heat at the time of resin film molding of the outer peripheral portion of the coil body 3 after pressing the core wire 2. The rate of increase in tensile strength at break was 1.2%, 1.1%, 1.0% in Examples 9, 10, and 11 and 0.6% in Examples 12 and 13, respectively. it can. Then, when converted to the rectangular cross-sectional area of the core wire 2 at the pressed portion, it can be increased by about 6.6 gf in Examples 9 to 11 and can be increased by about 4.4 gf in Examples 12 and 13. This means that the tensile breaking force between the core wire 2 and the leading plug 5 is around 250 gf, and the joint portion between the core wire 2 and the leading plug 5 requires repeated bending durability by manual operation by the operator within the stenotic lesion. In consideration of the fact that the number of repeated bending durability is expressed by a function of stress (S—N diagram), even a slight increase rate can contribute to improvement in durability, and the present invention This example discloses a new technical idea that partially improves the tensile rupture strength at a required location by using a resin film molding or heating a resin shrinkable tube without using a heat treatment furnace by atmospheric heating. It is.

そしてコイル体３の外周部の樹脂被膜６の成形時の熱を利用しても引張破断強度を向上させることができるのは、芯線２の先端部２１の押圧加工した矩形断面形状は前述のとおり、例えば板幅０．０９４ｍｍ、板厚０．０３０ｍｍの矩形断面の極細線形状であり、押圧加工による局部的に集中した応力の、より平均化によるもの、と考えることができる。又芯線２の先端部２１は、樹脂被膜６により密閉状態となっていて放熱しにくく、かつ、芯線先端部２１は細線で、かつその先端部は偏平状の極細線であって熱影響を受けやすく（熱容量小）、かつオーステナイト系ステンレス鋼線は熱伝導率が低く、冷めにくい材料であるからである。
そして温度範囲を１８０℃〜３００℃の温度範囲としたのは、後述するオーステナイト系ステンレス鋼線の温度による引張強度特性（図８）と、樹脂被膜成形時の合成樹脂の溶融温度、又オーステナイト系ステンレス鋼線の熱伝導性、及び樹脂被膜成形による密閉状態での保温効果を併せ考慮したからである。又、加熱時間を１０秒から６０分以内としたのは、１０秒を下回れば引張強度向上効果は得られず、又この範囲の上限を上回れば顕著な効果は期待できず、生産性を考慮したからである。尚、この加熱時間は、樹脂被膜成形加工と成形加工後の保温効果を有する時間も含まれる。 The tensile breaking strength can be improved even if the heat at the time of molding the resin coating 6 on the outer peripheral portion of the coil body 3 is used. For example, it can be considered to be an extra fine wire shape having a rectangular cross section with a plate width of 0.094 mm and a plate thickness of 0.030 mm, and more due to the averaging of locally concentrated stress caused by pressing. The tip 21 of the core wire 2 is hermetically sealed by the resin coating 6 so that it is difficult to dissipate heat. The tip of the core wire 21 is a thin wire and the tip is a flat extra fine wire that is affected by heat. This is because the austenitic stainless steel wire is easy (low heat capacity) and has a low thermal conductivity and is difficult to cool.
The temperature range was set to 180 ° C. to 300 ° C. because the tensile strength characteristics depending on the temperature of the austenitic stainless steel wire described later (FIG. 8), the melting temperature of the synthetic resin at the time of resin film molding, and the austenitic system This is because the heat conductivity of the stainless steel wire and the heat retaining effect in a sealed state by the resin film molding are considered together. Also, the heating time is set to within 10 to 60 minutes. If the heating time is less than 10 seconds, the effect of improving the tensile strength cannot be obtained, and if the heating time exceeds the upper limit of this range, a remarkable effect cannot be expected. Because. In addition, this heating time includes a time having a heat retention effect after the resin film forming process and the forming process.

次に、表４、５によると、芯線２の総減面率を９０％から９７．６％として、前記研削加工等の機械的加工後に、前記低温熱処理をすることにより芯線２の引張破断強度を２６０ｋｇｆ／ｍｍ²以上とし、製品の安定した品質を考慮すると２５０ｋｇｆ／ｍｍ²以上とすることができ、又芯線２の総減面率を９６％から９７．６％として、前記同様機械的加工後に、前記低温熱処理をすることにより芯線２の引張破断強度を３００ｋｇｆ／ｍｍ²以上とすることができ、高い引張強度特性を示す医療用ガイドワイヤを得ることができる。尚、本発明は高強度の芯線の為、芯線先端部に押圧加工を施す場合には、ひび割れ、欠損等の発生を抑える為、引張破断強度は３５０ｋｇｆ／ｍｍ²以下が望ましく、より好ましくは３２５ｋｇｆ／ｍｍ²以下である。 Next, according to Tables 4 and 5, the total area reduction rate of the core wire 2 was changed from 90% to 97.6%, and after the mechanical processing such as the grinding processing, the tensile breaking strength of the core wire 2 was obtained by performing the low temperature heat treatment. Is 260 kgf / mm ² or more, considering the stable quality of the product, it can be 250 kgf / mm ² or more, and the total area reduction of the core wire 2 is 96% to 97.6%. Later, by performing the low-temperature heat treatment, the tensile breaking strength of the core wire 2 can be increased to 300 kgf / mm ² or more, and a medical guide wire exhibiting high tensile strength characteristics can be obtained. Since the present invention is a high-strength core wire, it is desirable that the tensile strength at break is 350 kgf / mm ² or less, more preferably 325 kgf, in order to suppress the occurrence of cracks, defects, etc. when pressing the tip of the core wire. / Mm ² or less.

次に、芯線２に電気抵抗加熱下で捻回加工した後、低温熱処理の有無の芯線の引張破断強度と曲げ残留角度について、以下に述べる。 Next, after twisting the core wire 2 under electric resistance heating, the tensile breaking strength and the bending residual angle of the core wire with and without low-temperature heat treatment will be described below.

図５は、実施例６に対して、芯線２を電気抵抗加熱下で捻回回数を変化させたときの引張破断強度（図５（イ））と、前記電気抵抗加熱下で捻回加工後に低温熱処理（４５０℃、１２０分）を加えたときの引張破断強度（図５（ロ））を試料数各５０個のバラツキを含めて示したものであり、又図６は、前記図５と同様に芯線２を電気抵抗加熱下で捻回回数を変化させたときの曲げ試験後の曲げ残留角度（図６（イ））と、前記電気抵抗加熱下で捻回加工後に低温熱処理（４５０℃、１２０分）を加えたときの曲げ試験後の曲げ残留角度（図６（ロ））を示したものである。尚、ここでいう曲げ試験後での曲げ残留角度とは、芯線２を外径１５ｍｍの丸棒に１８０度曲げ、５００ｇの負荷を２０秒間保持した後、負荷を解除して芯線２の長軸方向に対する残留角度、つまり塑性変形した傾斜角度のことをいう。 FIG. 5 shows the tensile strength at break when the number of twists of the core wire 2 is changed under electrical resistance heating (FIG. 5 (a)) and the twisting process under the electrical resistance heating. FIG. 5 shows the tensile strength at break (FIG. 5 (b)) when low-temperature heat treatment (450 ° C., 120 minutes) is applied, including the variation of 50 samples, and FIG. Similarly, the bending residual angle after the bending test when the number of twists of the core wire 2 is changed under electrical resistance heating (FIG. 6 (a)) and the low-temperature heat treatment (450 ° C. after twisting under the electrical resistance heating). , 120 minutes), the bending residual angle after the bending test (FIG. 6B) is shown. The bending residual angle after the bending test mentioned here means that the core wire 2 is bent 180 degrees into a round bar having an outer diameter of 15 mm, a load of 500 g is held for 20 seconds, the load is released, and the long axis of the core wire 2 is released. It refers to the residual angle with respect to the direction, that is, the tilt angle that is plastically deformed.

図５、６によると引張破断強度は、捻回数が１００回／ｍから２７５回／ｍの間ではその変動幅は比較的小さく、この範囲を逸脱すると変動幅が大きくなり、つまり安定した品質を得ることはできなくなる。又、曲げ残留角度は、捻回数が１００回／ｍから２７５回／ｍの間で小さく、この範囲を逸脱すると変動幅が大きくなる。この理由は、１００回／ｍを下回ると捻回数が不足して芯線２の長軸方向に不均質な部分が残留していて、又２７５回／ｍ〜３２５回／ｍを超えると逆に、芯線の長軸方向に概ね４５度の傾きを成す滑り線（リューダース線）が発生する過捻回状態となって局部的に過捻回による不均質部分が散在発生する、と考えられるからである。従って、本発明の捻回は前記滑り線が発生するような過捻回を意味するものではない。
そして１００回／ｍから２００回／ｍの間で曲げ残留角度は最も小さくなって安定し、より好ましくは、１２０回／ｍから１８０回／ｍであり、さらに好ましくはこの捻回数の１０％から３０％、そして最も好ましくは、２０％逆捻回させることが望ましい。具体的には、例えば１２０回／ｍ一方向へ捻回後、逆方向へ１２回／ｍから３６回／ｍ、最も好きましくは２４回／ｍ逆方向へ捻回加工を行なう。これが望ましい理由は、一方向へ強加工捻回後の逆捻回により強加工捻回の捻り方向の応力を、逆捻回させて一時的に開放することにより低温熱処理効果を高め、より直線性の高い芯線２を得ることができる、と考えられるからである。 According to FIGS. 5 and 6, the tensile fracture strength is relatively small when the number of twists is between 100 times / m and 275 times / m, and if it exceeds this range, the fluctuation range becomes large, that is, stable quality is achieved. You can't get it. In addition, the bending residual angle is small when the number of twists is between 100 times / m and 275 times / m, and if the deviation is outside this range, the fluctuation range becomes large. The reason for this is that when the rotation speed is less than 100 turns / m, the number of twists is insufficient, and the inhomogeneous portion remains in the major axis direction of the core wire 2, and conversely, when it exceeds 275 times / m to 325 times / m, Because it is considered that a slip line (Ludders line) with an inclination of approximately 45 degrees in the major axis direction of the core wire is generated, and an inhomogeneous portion due to the over twist is locally scattered. is there. Therefore, the twisting of the present invention does not mean an overtwisting in which the slip line is generated.
The residual bending angle becomes the smallest and stable between 100 times / m and 200 times / m, more preferably from 120 times / m to 180 times / m, and even more preferably from 10% of the number of twists. It is desirable to reverse twist 30%, and most preferably 20%. Specifically, for example, after twisting in one direction 120 times / m, twisting is performed in the reverse direction 12 times / m to 36 times / m, most preferably 24 times / m in the reverse direction. The reason why this is desirable is to increase the low-temperature heat treatment effect by reverse-twisting and temporarily releasing the stress in the twist direction of strong work twist by reverse twist after strong work twist in one direction, and more linearity This is because it is considered that a high core wire 2 can be obtained.

そして図７は、芯線２に捻回加工と電気抵抗加熱を行なう装置図である。芯線２が巻かれたボビン１３から送りローラー１４Ａを介して保温ケース１６内へ芯線２を通過させて、芯線２を回転チャック９と芯線２の長軸方向へ移動可能な固定チャック１０で固定し、電流発生器８より通電可能状態にしてウエイト１２を負荷した状態で移動可能な固定チャック１０で芯線２を固定したまま回転チャック９にて芯線２を所定量一方向、又は逆方向へ捻回させる。具体的には、芯線２の外径が０．３４０ｍｍでチャック間９、１０の固定スパン間（図示Ｌ）が４０００ｍｍのとき、ウエイト１２を芯線２に負荷した状態で４００回から８００回一方向へ捻回加工を行なう。より好ましくは、逆方向へ前記捻回数の２０％、つまり８０回から１６０回逆方向へ捻回を加える。
そしてその電気抵抗加熱による低温熱処理下で捻回加工を行なった後、芯線２を回転チャック９と固定チャック１０からの固定を開放して、そして送りローラー１４Ａ、１４Ｂにて芯線２を図示左側へ送り出し、切断刃１５にて切断し、以後これを繰り返して連続的に直線性の優れた芯線２を得ることができる。尚、芯線に通電させて捻回数の増大に伴って徐変昇温させて電気抵抗加熱を行なってもよい。 FIG. 7 is an apparatus diagram for performing twisting processing and electric resistance heating on the core wire 2. The core wire 2 is passed from the bobbin 13 around which the core wire 2 is wound into the heat retaining case 16 through the feed roller 14A, and the core wire 2 is fixed by the rotary chuck 9 and the fixed chuck 10 that can move in the long axis direction of the core wire 2. The core wire 2 is twisted in a predetermined amount in one direction or in the reverse direction by the rotary chuck 9 while the core wire 2 is fixed by the fixed chuck 10 which can be energized by the current generator 8 and loaded with the weight 12. Let Specifically, when the outer diameter of the core wire 2 is 0.340 mm and the fixed span between the chucks 9 and 10 (L in the drawing) is 4000 mm, the weight 12 is loaded on the core wire 2 in one direction from 400 to 800 times. Perform twisting. More preferably, 20% of the number of twists is applied in the reverse direction, that is, 80 to 160 times in the reverse direction.
Then, after twisting under a low temperature heat treatment by electric resistance heating, the core wire 2 is released from the rotation chuck 9 and the fixed chuck 10, and the core wire 2 is moved to the left side in the drawing by the feed rollers 14A and 14B. The core wire 2 having excellent linearity can be continuously obtained by feeding and cutting with the cutting blade 15 and then repeating this. The electrical resistance heating may be performed by energizing the core wire and gradually increasing the temperature as the number of twists increases.

つまりこの工程は、ボビン１３に巻かれた芯線２を送りローラー１４Ａ、１４Ｂを介して電気抵抗加熱による保温ケース１６内へ送り出す（図示左側）工程と、送り出した後芯線２を回転チャック９と固定チャック１０で固定する工程と、ウエイト１２を連結させた固定チャック１０のストッパー１７を解除して固定チャック１０を長軸方向へ移動可能状態として芯線２に負荷荷重（ウエイト１２）を加える工程と、一定温度に保つ保温ケース１６内の芯線２に電流発生器８により電流を加えて通電する工程と、通電状態のままで固定チャック９により所定方向へ所定量の捻回加工する工程と、又は所定量の捻回加工中に徐変昇温させ芯線２に電流発生器８により電流を加えて通電する工程と、捻回加工後にストッパー１７を作動させて固定チャック１０の芯線２の固定を解除することによるウエイト１２側への移動（図示右側）を阻止する工程と、回転チャック９と固定チャック１０の芯線２の固定を解除する工程と、送りローラー１４Ａ、１４Ｂで芯線２を送り出す（図示左側）工程と、芯線２を所定量送り出した後、切断刃１５にて芯線２を切断する工程から成り、捻回して電気抵抗加熱による低温熱処理した芯線２を連続して生産できる工程である。又、芯線２を予め、所定長に切断後各チャックで固定して、電気抵抗加熱による低温熱処理下で前記同様の捻回加工を行なってもよい。 That is, in this process, the core wire 2 wound around the bobbin 13 is sent out into the heat retaining case 16 by electric resistance heating through the feed rollers 14A and 14B (the left side in the figure), and the core wire 2 after feeding is fixed to the rotary chuck 9 A step of fixing with the chuck 10, a step of releasing the stopper 17 of the fixed chuck 10 to which the weight 12 is connected and making the fixed chuck 10 movable in the long axis direction and applying a load (weight 12) to the core wire 2; A step of applying current by applying current to the core wire 2 in the heat retaining case 16 kept at a constant temperature by the current generator 8, and a step of twisting a predetermined amount in a predetermined direction by the fixed chuck 9 while being energized, or A process in which the temperature is gradually changed during a constant twisting process and a current is applied to the core wire 2 by a current generator 8, and a stopper 17 is operated and fixed after the twisting process. A step of preventing movement of the core wire 2 to the weight 12 side by releasing the fixation of the core wire 2 of the jack 10, a step of releasing the fixation of the core wire 2 of the rotary chuck 9 and the fixed chuck 10, and a feed roller 14A, 14B includes a step of feeding the core wire 2 (left side in the drawing) and a step of cutting the core wire 2 with a cutting blade 15 after feeding the core wire 2 by a predetermined amount. It is a process that can be produced. Alternatively, the core wire 2 may be preliminarily cut to a predetermined length and fixed with each chuck, and the same twisting process may be performed under a low-temperature heat treatment by electric resistance heating.

そして、電気抵抗加熱による低温熱処理温度は、３８０℃〜４９５℃で加熱加工時間は３０秒から６０分（本実施例では４５０℃、５分）である。又ウエイト１２は、最終伸線工程後の捻回加工前における芯線２の引張破断強度による芯線の引張破断力の５％から３０％が望ましく、より好ましくは１０％から２５％で最も好ましくは２０％である。
具体的には、実施例８のとき、線径が０．２２８ｍｍで最終伸線工程（二次伸線）後の捻回加工前の引張破断強度が３０２ｋｇｆ／ｍｍ²であることから芯線の引張破断力は１２．３２ｋｇｆ（π×０．２２８ ×３０２÷４）となり、このときウエイト１２は２．４６ｋｇｆ（１２．３２×０．２）が最も好ましい。
そしてこの５％から３０％の範囲を逸脱すると、ウエイト１２が軽いときにはうねりが発生したり、又重いときには捻回中に断線が発生したりして直線性の優れた芯線２を得ることができず、又生産性を高めることはできない。つまり、芯線２の捻回加工前の引張破断強度による引張破断力に応じてウエイト１２の重さを変化させることが重要である。尚、ここでいう引張破断力とは、芯線に引張力を加えて破断するときの最大荷重のことをいう。
以上述べたように、電気抵抗加熱と捻回加工条件は、電気抵抗加熱による低温熱処理条件として、３８０℃〜４９５℃で３０秒から６０分、そして捻回数は１００回／ｍから２７５回／ｍで、好ましくは１００回／ｍから２００回／ｍで、より好ましくは１２０回／ｍから１８０回／ｍであり、さらに好ましくは、逆方向へ前記捻回数の１０％から３０％、そしてウエイト１２は捻回加工前の芯線の引張破断力の５％から３０％が好ましく、最も好ましくは２０％である。そして、この全ての条件を満たすことにより医療用ガイドワイヤとして要求される引張強度特性、直線性、回転伝達性等の品質を満足させることができる。 And the low-temperature heat processing temperature by electrical resistance heating is 380 degreeC-495 degreeC, and heat processing time is 30 seconds to 60 minutes (this example 450 degreeC, 5 minutes). The weight 12 is preferably 5% to 30%, more preferably 10% to 25%, and most preferably 20% of the tensile breaking strength of the core wire due to the tensile breaking strength of the core wire 2 before the twisting after the final wire drawing step. %.
Specifically, in Example 8, since the wire diameter was 0.228 mm and the tensile strength before twisting after the final wire drawing step (secondary wire drawing) was 302 kgf / mm ² , the core wire was pulled. The breaking force is 12.32 kgf (π × 0.228 × 302 ÷ 4). At this time, the weight 12 is most preferably 2.46 kgf (12.32 × 0.2).
And if it deviates from the range of 5% to 30%, undulation occurs when the weight 12 is light, and breakage occurs during twisting when the weight 12 is heavy, so that the core wire 2 having excellent linearity can be obtained. In addition, productivity cannot be increased. That is, it is important to change the weight of the weight 12 in accordance with the tensile breaking force due to the tensile breaking strength before twisting of the core wire 2. Here, the tensile breaking force means the maximum load when the core wire is broken by applying a tensile force.
As described above, the electrical resistance heating and twisting processing conditions are low temperature heat treatment conditions by electrical resistance heating at 380 ° C. to 495 ° C. for 30 seconds to 60 minutes, and the number of twists is 100 times / m to 275 times / m. And preferably 100 times / m to 200 times / m, more preferably 120 times / m to 180 times / m, and still more preferably 10% to 30% of the number of twists in the reverse direction, and weight 12 Is preferably 5% to 30%, most preferably 20% of the tensile breaking strength of the core wire before twisting. And satisfy | filling all these conditions can satisfy quality, such as a tensile strength characteristic, linearity, and rotation transmission property which are requested | required as a medical guide wire.

次に、図８は実施例３、又は６の最終伸線工程後における芯線２に低温熱処理を加えた温度と引張強度特性を示した図で、線径１．５ｍｍの固溶化処理したオーステナイト系ステンレス鋼線（ＳＵＳ３０４）を総減面率９４．８％伸線加工した外径０．３４０ｍｍの芯線２を外周研削加工して外径０．１５０ｍｍとしたときの熱影響下（各温度３０分加熱）での引張強度特性を示したものである。
これによると、１８０℃の熱影響により引張破断強度が上昇し始め、概ね４５０℃近傍で最高の引張破断強度を示し、４９５℃まで引張強度特性向上効果が顕著にみられ、そして５００℃から５２０℃を超えると常温時（２０℃）よりも急激に引張破断強度が低下する。
この引張破断強度が急激に低下する理由は、前述のように、この固溶化処理したオーステナイト系ステンレス鋼線は、５００℃から５２０℃を超える８５０℃に加熱されると、カーボンの析出、クロムの移動の為のエネルギーを必要とし、鋭敏化現象を生じて、特にカーボンが０．０８％以下の通常のＳＵＳ３０４のオーステナイト系ステンレス鋼線では、７００℃４分から５分程度で、この鋭敏化現象が現れ、引張破断強度が極端に低下する。 Next, FIG. 8 is a view showing the temperature and tensile strength characteristics of the core wire 2 subjected to low-temperature heat treatment after the final wire drawing step of Example 3 or 6, and the austenite system having a wire diameter of 1.5 mm and subjected to solid solution treatment. Under the influence of heat when an outer diameter of 0.140 mm is obtained by grinding the core wire 2 having an outer diameter of 0.340 mm obtained by drawing a stainless steel wire (SUS304) with a total area reduction ratio of 94.8% (each temperature for 30 minutes) This shows the tensile strength characteristics during heating.
According to this, the tensile strength at break begins to increase due to the heat effect at 180 ° C., shows the highest tensile strength at about 450 ° C., and the effect of improving the tensile strength property is noticeable up to 495 ° C., and from 500 ° C. to 520 ° C. If it exceeds ℃, the tensile rupture strength decreases more rapidly than at normal temperature (20 ℃).
The reason why the tensile strength at break is drastically lowered is that, as described above, when the austenitic stainless steel wire subjected to the solution treatment is heated to 850 ° C. exceeding 500 ° C. to 520 ° C., precipitation of carbon, It requires energy for movement and causes a sensitization phenomenon. In particular, in a normal SUS304 austenitic stainless steel wire having a carbon content of 0.08% or less, this sensitization phenomenon occurs at 700 ° C. for about 4 to 5 minutes. Appears and the tensile strength at break decreases drastically.

このことは熱影響を受け易い芯線２の先端部２１の細線においては著しく顕著に現れる。例えば、図１（ハ）に示した芯線２の先端部２１の円形断面形状２３は、外径は線径０．０６０ｍｍから０．１５０ｍｍ程度であり、これは外径が概ね０．３４０ｍｍの伸線加工したオーステナイト系ステンレス鋼線を、芯なし研削機等により、前述した寸法まで外周研削加工を行う。
そしてこのときの引張破断強度が（図８）、例えば、常温で２５０ｋｇｆ／ｍｍ²の時、１８０℃の加熱により引張破断強度は２６６ｋｇｆ／ｍｍ²となって、約６．４％上昇し、４５０℃に至っては引張破断強度が２９０ｋｇｆ／ｍｍ²に向上して、約１６％上昇して、芯線の先端部２１の芯線２の外径が０．０６０ｍｍのときの引張破断力の断面積換算では７０６ｇｆが８１９ｇｆとなって約１１３ｇｆ引張強度が上昇する。その後４９５℃においても引張破断強度は２６０ｋｇｆ／ｍｍ²となって常温時よりも約４％上昇している。そして５００℃から５２０℃を超えると鋭敏化現象等により引張破断強度が低下し、６００℃に至っての引張破断強度は２１０ｋｇｆ／ｍｍ²となって、前記同様この部位の断面積で引張破断力を換算すると約８１９ｇｆが約５９３ｇｆとなって大幅に引張強度が低下し、極めて低い引張力で先端部２１の芯線２が破断することとなる。尚、図８の前記引張破断強度の常温での２５０ｋｇｆ／ｍｍ²の値は、伸線工程での総減面率の大小、及び研削加工の状態等により変動する値であり、又このときの温度と引張破断強度特性は前記と同様な傾向を示す。 This appears remarkably in the thin line at the tip 21 of the core wire 2 that is easily affected by heat. For example, the circular cross-sectional shape 23 of the distal end portion 21 of the core wire 2 shown in FIG. 1 (c) has an outer diameter of about 0.060 mm to 0.150 mm, and this is an extension having an outer diameter of about 0.340 mm. The austenitic stainless steel wire that has been subjected to wire processing is subjected to outer peripheral grinding to the above-described dimensions using a coreless grinding machine or the like.
And the tensile breaking strength at this time (FIG. 8), for example, when it is 250 kgf / mm ² at room temperature, the tensile breaking strength becomes 266 kgf / mm ² by heating at 180 ° C., and increases by about 6.4%. In the case of ℃, the tensile breaking strength is improved to 290 kgf / mm ² , increased by about 16%, and in terms of the sectional area of the tensile breaking force when the outer diameter of the core wire 2 at the tip end portion 21 of the core wire is 0.060 mm 706 gf becomes 819 gf, and the tensile strength of about 113 gf increases. Thereafter, even at 495 ° C., the tensile strength at break is 260 kgf / mm ² , which is about 4% higher than that at room temperature. When the temperature exceeds 500 ° C. to 520 ° C., the tensile rupture strength decreases due to a sensitization phenomenon or the like, and the tensile rupture strength up to 600 ° C. becomes 210 kgf / mm ^2. When converted, about 819 gf becomes about 593 gf, and the tensile strength is greatly lowered, and the core wire 2 of the distal end portion 21 is broken by an extremely low tensile force. Note that the value of 250 kgf / mm ² at room temperature for the tensile breaking strength in FIG. 8 is a value that varies depending on the total area reduction ratio in the wire drawing process, the state of grinding, and the like. The temperature and tensile strength characteristics show the same tendency as described above.

そして又、特に、接合部材４を用いる場合には、この熱影響による芯線２の引張強度特性等を考慮した接合部材４である共晶合金を用いないと、強加工による伸線加工で加工硬化させて引張強度特性を増大させた芯線２であるにも拘らず、芯線２とコイル体３との接合時の接合部材の溶融熱によって引張強度低下を招来させることとなり、そして術者の操作中に曲げ疲労により先導栓５と芯線２との接合部が破断して先導栓５が離脱する危険を生じさせる。 In particular, when the joining member 4 is used, if the eutectic alloy, which is the joining member 4 considering the tensile strength characteristics of the core wire 2 due to the thermal effect, is not used, the work hardening is performed by wire drawing by strong working. In spite of the core wire 2 having increased tensile strength characteristics, the tensile strength is reduced due to the heat of fusion of the joining member when the core wire 2 and the coil body 3 are joined. Further, the joint between the leading plug 5 and the core wire 2 is broken due to bending fatigue, and the leading plug 5 may be detached.

このような引張強度特性を有する為、芯線２の低温熱処理温度範囲は１８０℃から４９５℃が望ましく、前記表１、２、３における最終伸線後の低温熱処理温度４５０℃は好適条件であり、又機械的加工後の、特にフッ素樹脂（ＰＴＦＥ）被膜成形熱を利用した３８５℃の低温熱処理においてもその効果は顕著であり、そして前記表４、５に見られるように芯線２に押圧加工後のコイル体３の外周部に樹脂被膜成形熱を利用した２００℃の低温熱処理においても、引張破断強度を向上させることができる。（図８）
このように本発明は、強加工伸線して総減面率の高いオーステナイト系ステンレス鋼線の温度による引張強度特性に着目して伸線加工後に好適な低温熱処理を行い、そして一定温度範囲に制御した状態での樹脂被膜成形時の熱を利用し、さらに保温性、熱伝導性、構造、材質とを併せ考慮して芯線２の引張強度特性を大幅に向上できる、新たな技術思想を提供するものである。 Since it has such tensile strength characteristics, the low temperature heat treatment temperature range of the core wire 2 is desirably 180 ° C. to 495 ° C., and the low temperature heat treatment temperature 450 ° C. after the final wire drawing in Tables 1, 2, and 3 is a preferable condition. In addition, the effect is remarkable even in the low-temperature heat treatment at 385 ° C. using the heat of forming a fluororesin (PTFE) film after mechanical processing, and after pressing the core wire 2 as shown in Tables 4 and 5 above. The tensile strength at break can be improved even in a low-temperature heat treatment at 200 ° C. using resin film forming heat on the outer periphery of the coil body 3. (Fig. 8)
As described above, the present invention focuses on the tensile strength characteristics depending on the temperature of the austenitic stainless steel wire with high work drawing and a high total area reduction rate, and performs a suitable low temperature heat treatment after the drawing, and within a certain temperature range. Providing a new technical concept that can significantly improve the tensile strength characteristics of the core wire 2 by taking into account heat retention, thermal conductivity, structure, and materials, using heat during resin film molding in a controlled state To do.

そして次に、前述したような引張強度特性を有する為の芯線の伸線加工方法について実施例６を用いて、以下説明する。 Next, a core wire drawing method for having the tensile strength characteristics as described above will be described below with reference to Example 6.

前述したように、固溶化処理したオーステナイト系ステンレス鋼線を用いて図８に示すような高強度の引張強度特性を有する芯線２を得る為には、単純に総減面率９４．８％の伸線加工のみによって得られるものではない。例えば実施例３、６では、線径１．５ｍｍの固溶化処理したオーステナイト系ステンレス鋼線を、各ダイスの減面率が４％から２０％複数のダイス（１０〜２０個）を用いて連続伸線加工により線径０．５ｍｍまで一次伸線加工（減面率８８．９％）を行い、その後低温熱処理（４２０℃、７５分）を行い、さらに一次伸線加工と同様一定の減面率を有する複数のダイス（５〜８個）を用いて連続伸線加工により線径０．３４０ｍｍまで二次伸線加工（減面率５３．８％）を行い、総減面率９４．８％とすることにより所望の引張強度特性を有する芯線２、及びその先端部２１を得ることができる。このとき、一次伸線加工の減面率は、二次伸線加工の減面率よりも高い減面率とするほうが結晶粒径を小さくさせ、又経済性、生産性向上等の観点からより望ましい。
補足すれば、ダイス材質は本実施例のような高強度材料の伸線の場合には、合金ダイスよりも耐磨耗性に優れるダイヤモンドダイスが望ましい。 As described above, in order to obtain a core wire 2 having a high strength tensile strength characteristic as shown in FIG. 8 using a solution-treated austenitic stainless steel wire, the total area reduction rate is simply 94.8%. It is not obtained only by wire drawing. For example, in Examples 3 and 6, a solidified austenitic stainless steel wire having a wire diameter of 1.5 mm was continuously used by using a plurality of dies (10 to 20 pieces) each having a surface area reduction rate of 4% to 20%. Performs primary wire drawing to a wire diameter of 0.5 mm by wire drawing (area reduction rate: 88.9%), followed by low-temperature heat treatment (420 ° C., 75 minutes), and constant surface reduction as with primary wire drawing. Secondary drawing (53.8% area reduction) is performed by continuous drawing using a plurality of dies (5 to 8) having a rate to a wire diameter of 0.340 mm, and the total area reduction rate is 94.8. %, The core wire 2 having a desired tensile strength characteristic and the tip portion 21 thereof can be obtained. At this time, the area reduction rate of the primary wire drawing is smaller than the area reduction rate of the secondary wire drawing, so that the crystal grain size is reduced, and from the viewpoint of economy, productivity improvement, etc. desirable.
In addition, in the case of drawing a high-strength material as in the present embodiment, a diamond die that is more excellent in wear resistance than an alloy die is desirable.

そして、最終伸線工程において、減面率が４％から２０％複数のダイス（５個〜８個）を用いて、かつ複数のダイス（５個〜８個）のうち最終ダイスの減面率を４％から１３％として最終伸線工程内で最も小さい減面率を有するダイス配列とすることにより、最終伸線工程での断線を防ぐことができ、生産性が高く、又安定した品質の芯線を得ることができる。
又、本実施例のオーステナイト系ステンレス鋼線の化学成分は、重量％でＣ：０．１５％以下、Ｓｉ：１％以下、Ｍｎ：２％以下、Ｎｉ：６％〜１６％、Ｃｒ：１６％〜２０％、Ｐ：０．０４５％以下、Ｓ：０．０３０％以下、Ｍｏ：３％以下、残部鉄及び不可避的不純物から成る。このように高珪素ステンレス鋼（Ｓｉ：３．０％〜５．０％）を用いなくても前記工程を用いることにより、高強度のオーステナイト系ステンレス鋼線の芯線２を得ることができる。代表的にはＳＵＳ３０４、ＳＵＳ３１６材である。 In the final wire drawing step, the area reduction rate is 4% to 20%. Using the plurality of dies (5 to 8), the area reduction ratio of the final die out of the plurality of dies (5 to 8). By making the die arrangement having the smallest surface area reduction ratio in the final wire drawing process from 4% to 13%, disconnection in the final wire drawing process can be prevented, productivity is high, and stable quality is achieved. A core wire can be obtained.
Further, the chemical components of the austenitic stainless steel wire of this example are C: 0.15% or less, Si: 1% or less, Mn: 2% or less, Ni: 6% to 16%, Cr: 16 by weight%. %: 20%, P: 0.045% or less, S: 0.030% or less, Mo: 3% or less, balance iron and inevitable impurities. Thus, even if it does not use high silicon stainless steel (Si: 3.0%-5.0%), the core wire 2 of a high-strength austenitic stainless steel wire can be obtained by using the said process. Typically, SUS304 and SUS316 material.

そして次に、固溶化処理したオーステナイト系ステンレス鋼線を伸線加工して低温熱処理を加えたときの引張強度特性が図８に示す特性を有することから低温熱処理効果を高める別に方法について、以下説明する。 Next, another method for enhancing the low-temperature heat treatment effect will be described below because the tensile strength characteristics when the solution-treated austenitic stainless steel wire is drawn and subjected to low-temperature heat treatment are shown in FIG. To do.

図８に示すように、低温熱処理温度が１８０℃から４９５℃で引張破断強度の向上効果が得られることから、芯線２とコイル体３とを部分的に接合する接合部材４１、４２、４３又は先導栓５が、１８０℃から４９５℃の溶融温度を持つ共晶合金を用いることによっても引張破断強度を向上させることができる。具体的には、接合部材４１、４２は幅約０．３ｍｍから１．５ｍｍ程度で外径が０．２２８ｍｍから０．３４０ｍｍ程度のドーナツ状の略円板形状であり、又後端接合部材４３は、前記放射線透過コイル材３２と線径０．２００ｍｍから０．３４０ｍｍ程度の芯線２との接合で、その接合形状は、幅約０．３ｍｍから３ｍｍ程度で外径が０．２２８ｍｍ程から０．３４０ｍｍ程度の円板状、又は手元側が先細りの略円錐形状である。尚、ここでいう接合部材４を用いて部分的に接合するとは、前記例で各接合部材４１〜４３及び先導栓５の接合形態のことをいう。 As shown in FIG. 8, since the low temperature heat treatment temperature is 180 ° C. to 495 ° C. and the effect of improving the tensile breaking strength is obtained, the joining members 41, 42, 43 that partially join the core wire 2 and the coil body 3 or The tensile strength at break can also be improved by using a eutectic alloy having a melting temperature of 180 to 495 ° C. for the leading plug 5. Specifically, the joining members 41 and 42 are donut-shaped substantially disk shapes having a width of about 0.3 mm to 1.5 mm and an outer diameter of about 0.228 mm to 0.340 mm, and the rear end joining member 43. Is a joint between the radiation transmitting coil member 32 and the core wire 2 having a wire diameter of about 0.200 mm to 0.340 mm. The joint shape is about 0.3 mm to 3 mm in width and the outer diameter is about 0.228 mm to 0. A disc shape of about 340 mm, or a substantially conical shape with a tapered side. In addition, to join partially using the joining member 4 here means the joining form of each joining member 41-43 and the leading plug 5 in the said example.

そしてここでいう接合部材４に用いる共晶合金とは、合金の成分比を変更することにより得られる最低融点（溶融温度）を有する特殊な合金のことをいい、具体的には、金又は銀を含む合金材で金錫系合金材として金８０重量％、残部が錫で溶融温度が２８０℃、又銀錫系合金として銀３．５重量％、残部が錫で溶融温度が２２１℃、そして、金８８重量％、残部がゲルマニウムで溶融温度が３５６℃、又銀と錫とインジウムから成り溶融温度が４５０℃から４７２℃の共晶合金であり、その代表例を表６に示す。 And the eutectic alloy used for the joining member 4 here means a special alloy having the lowest melting point (melting temperature) obtained by changing the component ratio of the alloy, specifically, gold or silver. 80% by weight as a gold-tin alloy material with a balance of tin and a melting temperature of 280 ° C., and 3.5% by weight of silver as a silver-tin alloy, with a balance of tin and a melting temperature of 221 ° C., and An eutectic alloy consisting of 88% by weight of gold, the balance being germanium and a melting temperature of 356 ° C., consisting of silver, tin and indium and having a melting temperature of 450 ° C. to 472 ° C. is shown in Table 6.

そして、例えば、図１０に示すように先導栓５の先端から５０ｍｍ（図示Ａ寸法）に位置する中間接合部材４１１と中間接合部材４１２、４１３との各間隔を１０ｍｍ（図示Ｂ寸法）として前記同様の中間接合部材を１０個配置して中間接合部材間の全長を９０ｍｍとすることにより、部分的に接合する接合部材を用いても芯線２の長尺位置（図示９０ｍｍ）にわたって低温熱処理を施すことができ、芯線２の引張強度特性を高めることができる。
この方法によれば、全体加熱する雰囲気加熱による熱処理炉を用いなくても、部分的に一定の狭い範囲であっても必要部位の芯線２の引張強度を向上させることがでる。
そしてさらに、この構造体では、等間隔の中間接合部材４１１、４１２、４１３の配置とすることにより、狭窄病変長の計測が可能となる効果を併せもつことができる。尚、中間接合部材の位置、及びその範囲を前記寸法としたのは、この範囲であれば、一般的に冠状動脈に多く見られる狭窄病変位置に該当するからである。
そして補足すれば、先導栓５に共晶合金である接合部材４を用いることにより、先導栓５と芯線２の接合部での芯線２の引張破断強度を向上させることができ、その結果狭窄病変内で前記接合部での耐屈曲疲労特性を向上させることができる。尚、補足すれば、この接合工程は先端部２１の機械的加工の研削工程の後の低温熱処理（３８５℃、３０分）後に、先端部２１の外周部にコイル体３を装着し、その後接合部材４を用いて接合部材４１〜４３、４１１、４１２、４１３の接合、及び先導栓５を接合する。その後コイル体３の外周部に樹脂被膜を施す工程となる。 For example, as shown in FIG. 10, each interval between the intermediate joining member 411 and the intermediate joining members 412 and 413 located 50 mm (A dimension in the figure) from the tip of the leading plug 5 is set to 10 mm (B dimension in the figure). By arranging 10 intermediate joining members and setting the total length between the intermediate joining members to 90 mm, low-temperature heat treatment is performed over a long position (90 mm in the figure) of the core wire 2 even when a joining member that is partially joined is used. The tensile strength characteristic of the core wire 2 can be improved.
According to this method, it is possible to improve the tensile strength of the core wire 2 at a necessary portion even without using a heat treatment furnace by atmospheric heating that heats the whole, even in a partially narrow range.
Furthermore, in this structure, by arranging the intermediate joint members 411, 412, and 413 at equal intervals, it is possible to have an effect that the length of the stenotic lesion can be measured. The reason why the position and the range of the intermediate joint member are the above dimensions is that this range corresponds to a stenotic lesion position generally observed in the coronary artery.
If it supplements, by using the joining member 4 which is a eutectic alloy for the leading plug 5, the tensile fracture strength of the core wire 2 in the junction part of the leading plug 5 and the core wire 2 can be improved, As a result, a stenosis lesion The bending fatigue resistance characteristics at the joint can be improved. In addition, in addition, in this joining process, the coil body 3 is attached to the outer peripheral portion of the tip 21 after the low-temperature heat treatment (385 ° C., 30 minutes) after the grinding process of the mechanical processing of the tip 21, and then joined. Using the member 4, the joining members 41 to 43, 411, 412, 413 and the leading plug 5 are joined. Thereafter, a step of applying a resin coating to the outer peripheral portion of the coil body 3 is performed.

次に、本発明の芯線２をもつ医療用ガイドワイヤを用いることにより、芯線２の引張強度特性向上作用を利用して、芯線２を細径化することが可能となる。例えば、医療用ガイドワイヤ１の手元部２２の外径が０．３５５ｍｍから０．２５４ｍｍ（０．０１４インチから０．０１０インチ）へ、さらに樹脂被膜６の成形熱、コイル体３内の樹脂被膜密閉状態での成形余熱を利用して、先端部２１の芯線２の引張強度特性を向上させることができ、その結果、芯線２の外径が０．２２８ｍｍ（０．００９インチ）へ細径化できる。
そして、医療用ガイドワイヤをマイクロカテーテル内へ挿入し、かつ、ガイディングカテーテル内へ前記ガイドワイヤとマイクロカテーテルとを挿入する。かかる場合において、医療用ガイドワイヤ１の細径化に追従してガイディングカテーテルは７Ｆ〜８Ｆから５Ｆ〜６Ｆ（内径２．３ｍｍ〜２．７ｍｍから内径１．５９ｍｍ〜２．００ｍｍ）となり、この中に挿入するマイクロカテーテル（内径０．２８ｍｍから０．９０ｍｍ）とともに細径化することができる。これにより低侵襲化の要請に応えることができ、又患者負担軽減に寄与することができる。尚補足すれば、前記マイクロカテーテルは、医療用ガイドワイヤとともに狭窄病変端まで導入して、医療用ガイドワイヤの前方へ押す力の反力を、前記マイクロカテーテルで支えることにより、医療用ガイドワイヤの前方への推進力を発揮させることができる。又、前記マイクロカテーテルは、多層樹脂管体、多層樹脂管体内に金属線の編組を介在させた構造の他、先端部に略円錐状の金属製チップが固着されて、複数の金属細線を多条コイル体に成形した螺旋状管体から成り、狭窄病変内の穿孔可能とした前記螺旋状管体も含まれる。 Next, by using the medical guide wire having the core wire 2 of the present invention, the core wire 2 can be reduced in diameter by utilizing the effect of improving the tensile strength characteristics of the core wire 2. For example, the outer diameter of the proximal portion 22 of the medical guide wire 1 is changed from 0.355 mm to 0.254 mm (0.014 inch to 0.010 inch), the molding heat of the resin coating 6, and the resin coating in the coil body 3 The tensile strength characteristics of the core wire 2 at the tip 21 can be improved by utilizing the residual heat in the sealed state, and as a result, the outer diameter of the core wire 2 is reduced to 0.228 mm (0.009 inch). it can.
Then, a medical guide wire is inserted into the microcatheter, and the guide wire and the microcatheter are inserted into the guiding catheter. In such a case, the guiding catheter is changed from 7F to 8F to 5F to 6F (inner diameter 2.3 mm to 2.7 mm to inner diameter 1.59 mm to 2.00 mm) following the thinning of the medical guide wire 1. The diameter can be reduced with a microcatheter (inner diameter 0.28 mm to 0.90 mm) inserted therein. Thereby, the request | requirement of minimally invasiveness can be met and it can contribute to a patient burden reduction. If supplemented, the microcatheter is introduced to the end of the stenotic lesion together with the medical guidewire, and the reaction force of the force pushing the front of the medical guidewire is supported by the microcatheter, whereby the medical guidewire The forward driving force can be demonstrated. The microcatheter has a multi-layer resin tube and a structure in which a braid of metal wires is interposed in the multi-layer resin tube, and a substantially conical metal tip is fixed to the distal end portion so that a plurality of thin metal wires are arranged. The spiral tube body that is formed of a spiral tube body formed into a strip coil body and that can be perforated in a stenotic lesion is also included.

そして次に、前記同様本発明の芯線２をもつ医療用ガイドワイヤを用いることにより、例えば、医療用ガイドワイヤ１の手元部２２の外径が０．３５５ｍｍから０．２５４ｍｍ（０．００１４インチから０．０１０インチ）へ、さらに０．２２８ｍｍ（０．００９インチ）へ細径化でき、そして、医療用ガイドワイヤをバルーンカテーテル内へ挿入し、かつ、ガイディングカテーテル内へ前記ガイドワイヤとバルーンカテーテルとを挿入する。かかる場合において、医療用ガイドワイヤ１の細径化に追従してガイディングカテーテルは７Ｆ〜８Ｆから５Ｆ〜６Ｆ（内径２．３ｍｍ〜２．７ｍｍから内径１．５９ｍｍ〜２．００ｍｍ）となり、この中へ挿入するバルーンカテーテル（内径０．２８ｍｍから０．９０ｍｍ）とともに細径化することができる。これにより低侵襲化の要請に応えることができ、又患者負担軽減に寄与することができる。尚補足すれば、前記ガイディングカテーテル内へ医療用ガイドワイヤとバルーンカテーテルとを一組として二組挿入してキッシング手技を容易に行なうことができる。ここでいうキッシング手技とは、ガイディングカテーテル内へ二組の医療用ガイドワイヤとバルーンカテーテルとを挿入して分岐病変部にて、バルーンカテーテルのバルーン部を同時拡張させ、分岐病変部の分岐箇所の狭窄病変部を同時拡張させる手技のことをいう。 And next, by using the medical guide wire having the core wire 2 of the present invention as described above, for example, the outer diameter of the proximal portion 22 of the medical guide wire 1 is 0.355 mm to 0.254 mm (from 0.0014 inch). 0.010 inch) and further 0.228 mm (0.009 inch) diameter, and a medical guide wire is inserted into the balloon catheter and the guide wire and balloon catheter are inserted into the guiding catheter. And insert. In such a case, the guiding catheter is changed from 7F to 8F to 5F to 6F (inner diameter 2.3 mm to 2.7 mm to inner diameter 1.59 mm to 2.00 mm) following the thinning of the medical guide wire 1. The diameter can be reduced with a balloon catheter (inner diameter 0.28 mm to 0.90 mm) inserted therein. Thereby, the request | requirement of minimally invasiveness can be met and it can contribute to a patient burden reduction. If supplemented, a kissing procedure can be easily performed by inserting two sets of medical guidewires and balloon catheters into the guiding catheter. The kissing technique here refers to the branching site of the bifurcated lesion by inserting two pairs of medical guide wires and a balloon catheter into the guiding catheter and simultaneously expanding the balloon catheter balloon at the bifurcated lesion. This refers to a procedure that simultaneously expands the stenotic lesion.

［発明の効果］
以上説明のとおり、本発明の医療用ガイドワイヤ、及びその製造方法は伸線限界に近い強加工の伸線加工を行なったオーステナイト系ステンレス鋼線の温度による引張強度特性に着目して、好適な伸線加工と一定温度範囲の低温熱処理を繰り返しながら、そして医療用ガイドワイヤとしての直線性、回転伝達性を得る為の低温熱処理下での捻回加工を行い、さらに機械的加工後に一定温度範囲の低温熱処理を加えることにより、医療用ガイドワイヤとしての特有の各加工工程毎に芯線の引張強度向上効果を累積することにより、高度の引張強度特性を有する医療用ガイドワイヤとその製造方法を提供するものである。 [The invention's effect]
As described above, the medical guide wire of the present invention and the manufacturing method thereof are suitable by paying attention to the temperature-dependent tensile strength characteristics of the austenitic stainless steel wire that has been subjected to strong wire drawing close to the wire drawing limit. Twisting is performed under low temperature heat treatment to obtain linearity and rotation transferability as a medical guide wire while repeating wire drawing and low temperature heat treatment within a certain temperature range, and after a mechanical processing, a certain temperature range By providing the low-temperature heat treatment, accumulating the effect of improving the tensile strength of the core wire for each specific processing step as a medical guidewire, and providing a medical guidewire with a high tensile strength characteristic and its manufacturing method To do.

そしてさらに、芯線２の先端部２１の機械的加工後の手元部２２の比較的高温での外周部樹脂被膜成形の乾燥・焼成加熱の利用、及び芯線２の先端部２１の研削加工後、及び押圧加工後のコイル体３の外周部に樹脂被膜成形温度による加熱と、強加工芯線の温度による引張強度特性との相関性に着目して、一定温度範囲に制御した低温熱処理を加えることにより芯線２を全体的に、又は部分的であっても引張強度特性等向上させる新たな技術思想を提供するものである。
これにより医療用ガイドワイヤの先端部が極細線でありながら機械的強度特性を、より向上させ、又品質安定を図ることができる。以上の諸効果がある。 And further, after the mechanical processing of the distal end portion 21 of the core wire 2, use of drying / firing heating of the outer peripheral resin film molding at a relatively high temperature, and after the grinding processing of the distal end portion 21 of the core wire 2, and Focusing on the correlation between heating at the outer periphery of the coil body 3 after pressing and the tensile strength characteristics due to the temperature of the hard-working core wire, by applying low-temperature heat treatment controlled to a certain temperature range, the core wire The present invention provides a new technical idea for improving the tensile strength characteristics, etc., even if 2 is wholly or partially.
As a result, the mechanical strength characteristics can be further improved and the quality can be stabilized while the distal end portion of the medical guide wire is an extra fine wire. There are the above various effects.

１ガイドワイヤ（医療用ガイドワイヤ）５先導栓
２芯線６樹脂被膜
２１先端部（芯線）７親水性被膜
３コイルスプリング体（コイル体）８電流発生器
３１放射線不透過材コイル９回転チャック
３２放射線透過材コイル１０固定チャック
４接合部材１１移動ローラー
４１中間前側接合部材１２ウエイト
４２中間後側接合部材１３ボビン
４３後端接合部材１４Ａ送りローラー
１４Ｂ送りローラー
１５切断刃 DESCRIPTION OF SYMBOLS 1 Guide wire (medical guide wire) 5 Lead plug 2 Core wire 6 Resin coating 21 Tip part (core wire) 7 Hydrophilic coating 3 Coil spring body (coil body) 8 Current generator 31 Radiopaque material coil 9 Rotary chuck 32 Radiation Transmission material coil 10 Fixed chuck 4 Joining member 11 Moving roller 41 Intermediate front joining member 12 Weight 42 Middle rear joining member 13 Bobbin 43 Rear end joining member 14A Feeding roller
14B feed roller
15 Cutting blade

Claims

可とう性細長体から成る芯線と、前記芯線の先端部に前記芯線を貫挿したコイルスプリング体を装着し、前記芯線と前記コイルスプリング体との先端端部に接合部材を用いて先導栓を形成して、少なくとも前記芯線手元部の外周部に樹脂被膜を形成した医療用ガイドワイヤにおいて、
前記芯線が固溶化処理したオーステナイト系ステンレス鋼線を用いて、伸線工程と前記伸線工程後に４００℃〜４９５℃の低温熱処理工程を設けて、
前記伸線工程と前記低温熱処理工程を１セットとして少なくとも１セット以上各工程を繰り返した後に最終伸線工程を設けて、
前記最終伸線工程までの総減面率を９０％から９７．６％とし、
前記最終伸線工程までの低温熱処理による引張破断強度の増加率の合計が８％以上とし、
前記最終伸線工程後に、前記芯線に電気抵抗加熱による３８０℃〜４９５℃の低温熱処理下で所定量の捻回加工を行い、
その後前記芯線先端部の研削加工、又は押圧加工の機械的加工をした後に、前記芯線外周部に樹脂被膜成形の熱を利用して３４０℃〜４２０℃の低温熱処理を行い、
前記最終伸線工程後の各低温熱処理による引張破断強度の増加率の合計が２％以上とし、
前記各低温熱処理による引張破断強度の増加率の合計が１０％以上であることを特徴とする医療用ガイドワイヤ。 A core wire made of a flexible elongated body, a coil spring body having the core wire inserted through the distal end portion of the core wire, and a leading plug using a joining member at the distal end ends of the core wire and the coil spring body In a medical guide wire formed and formed with a resin coating on at least the outer peripheral portion of the core wire proximal portion,
Using the austenitic stainless steel wire in which the core wire is subjected to a solution treatment, a low-temperature heat treatment step of 400 ° C. to 495 ° C. is provided after the wire drawing step and the wire drawing step,
The wire drawing step and the low temperature heat treatment step are set as one set, and after each step is repeated at least one set, a final wire drawing step is provided.
The total area reduction until the final wire drawing step is 90% to 97.6%,
The total increase rate of tensile fracture strength by low-temperature heat treatment until the final wire drawing step is 8% or more,
After the final wire drawing step, the core wire is twisted by a predetermined amount under a low temperature heat treatment of 380 ° C. to 495 ° C. by electric resistance heating,
Then, after grinding of the core wire tip or mechanical processing of pressing, a low temperature heat treatment of 340 ° C. to 420 ° C. is performed on the outer periphery of the core wire using the heat of resin film molding,
The total increase rate of tensile fracture strength by each low-temperature heat treatment after the final wire drawing step is 2% or more,
A medical guide wire, wherein the total increase rate of tensile breaking strength by each of the low-temperature heat treatments is 10% or more.

請求項１記載の医療用ガイドワイヤにおいて、
前記最終伸線工程後に、前記芯線に電気抵抗加熱による３８０℃〜４９５℃の低温熱処理下での所定量の捻回加工が、
前記最終伸線工程後に、前記芯線に所定量の捻回加工を行い、
前記捻回加工の捻回数の増大に伴って前記芯線に電気抵抗加熱により徐変昇温させて
３８０℃〜４９５℃を最高温度とする低温熱処理下での捻回加工としたことを特徴とする医療用ガイドワイヤ。 The medical guidewire according to claim 1, wherein
After the final wire drawing step, the core wire is subjected to a predetermined amount of twisting under low temperature heat treatment at 380 ° C. to 495 ° C. by electric resistance heating,
After the final wire drawing step, a predetermined amount of twisting is performed on the core wire,
With the increase in the number of twists in the twisting process, the core wire is gradually changed in temperature by electric resistance heating, and the twisting process is performed under a low-temperature heat treatment in which the maximum temperature is 380 ° C. to 495 ° C. Medical guide wire.

請求項１〜２のいずれか一つに記載の医療用ガイドワイヤにおいて、
前記芯線先端部の機械的加工後、前記芯線の外周部の樹脂被膜成形前に
４００℃〜４９５℃の低温熱処理工程を設けて、
引張破断強度を前記芯線の機械的加工後の引張破断強度に対して増大させ、
前記各低温熱処理による引張破断強度の増加率の合計が１１．５％以上であることを特徴とする医療用ガイドワイヤ。 The medical guidewire according to any one of claims 1 to 2,
After mechanical processing of the tip of the core wire, before forming a resin film on the outer peripheral portion of the core wire, a low temperature heat treatment step of 400 ° C. to 495 ° C. is provided,
Increasing the tensile breaking strength relative to the tensile breaking strength after mechanical processing of the core wire,
A medical guide wire characterized in that the total increase rate of tensile breaking strength by each of the low-temperature heat treatments is 11.5% or more.

請求項１〜３のいずれか一つに記載の芯線を用いて、前記芯線の先端部に前記芯線を貫挿したコイルスプリング体を装着し、前記芯線と前記コイルスプリング体との先端端部に接合部材を用いて先導栓を形成し、少なくとも前記コイルスプリング体の外周部に樹脂被膜を形成した医療用ガイドワイヤにおいて、
前記芯線先端部の研削加工した部分の低温熱処理後に押圧加工を行い、
少なくとも押圧加工した部分に前記先端部コイルスプリング体外周部の樹脂被膜成形熱を利用して１８０℃〜３００℃の低温熱処理を行い、
少なくとも前記芯線先端部研削、又は押圧加工部分の引張破断強度を、前記樹脂被膜成形の低温熱処理前の引張破断強度に対して増大させたことを特徴とする医療ガイドワイヤ。 Using the core wire according to any one of claims 1 to 3, a coil spring body that is inserted through the core wire is attached to a tip end portion of the core wire, and a tip end portion of the core wire and the coil spring body is attached. In a medical guide wire in which a leading plug is formed using a joining member, and a resin film is formed at least on the outer periphery of the coil spring body,
Press processing after low-temperature heat treatment of the ground portion of the core wire tip,
Perform a low-temperature heat treatment at 180 ° C. to 300 ° C. using the resin film forming heat of the outer periphery of the tip coil spring body on at least the pressed portion,
A medical guide wire characterized in that at least the tensile breaking strength of the core wire tip grinding or pressing portion is increased with respect to the tensile breaking strength before low-temperature heat treatment of the resin film molding.

請求項１〜４のいずれか一つに記載の医療用ガイドワイヤにおいて、
前記芯線の最終伸線加工までの総減面率を９４％から９７．６％としたことを特徴とする医療用ガイドワイヤ。 The medical guidewire according to any one of claims 1 to 4,
A medical guide wire characterized in that the total area reduction ratio until the final wire drawing of the core wire is 94% to 97.6%.

可とう性細長体から成る芯線と、前記芯線の先端部に前記芯線を貫挿したコイルスプリング体を装着し、前記芯線と前記コイルスプリング体との先端端部に接合部材を用いて先導栓を形成した医療用ガイドワイヤにおいて、
前記芯線が固溶化処理したオーステナイト系ステンレス鋼線を用いて、伸線工程と前記伸線工程後に４００℃〜４９５℃で１０分から１８０分の低温熱処理工程を設けて、
前記伸線工程と前記低温熱処理工程を１セットとして少なくとも１セット以上各工程を繰り返した後に最終伸線工程を設けて、
前記最終伸線工程までの総減面率を９０％から９７．６％とし、
その後前記芯線に電気抵抗加熱による３８０℃〜４９５℃で３０秒から６０分の低温熱処理下で、
前記芯線の一端に捻回加工前の芯線の引張破断力の５％から３０％の負荷荷重を加えた状態で、他端を１００回／ｍから２７５回／ｍの捻回加工工程を設け、
前記芯線先端部を研削加工、又は研削加工後に押圧加工する工程と、
前記芯線の先端部に前記芯線を貫挿してコイルスプリング体を装着する工程と、
前記接合部材を用いて前記芯線と前記コイルスプリング体とを部分的に接合させる工程と、
前記接合部材を用いて前記芯線と前記コイルスプリング体の端部とを接合させた先導栓を形成する工程から成ることを特徴とする医療用ガイドワイヤの製造方法。 A core wire made of a flexible elongated body, a coil spring body having the core wire inserted through the distal end portion of the core wire, and a leading plug using a joining member at the distal end ends of the core wire and the coil spring body In the formed medical guidewire,
Using the austenitic stainless steel wire in which the core wire is subjected to a solution treatment, a low-temperature heat treatment step is performed at 400 to 495 ° C. for 10 minutes to 180 minutes after the wire drawing step and the wire drawing step,
The wire drawing step and the low temperature heat treatment step are set as one set, and after each step is repeated at least one set, a final wire drawing step is provided.
The total area reduction until the final wire drawing step is 90% to 97.6%,
Thereafter, the core wire is subjected to low-temperature heat treatment at 380 ° C. to 495 ° C. by electric resistance heating for 30 seconds to 60 minutes,
In the state where a load of 5% to 30% of the tensile breaking force of the core wire before twisting is applied to one end of the core wire, the other end is provided with a twisting process of 100 times / m to 275 times / m,
Grinding the core wire tip, or pressing after grinding, and
Attaching the coil spring body by inserting the core wire through the tip of the core wire;
A step of partially bonding the core wire and the coil spring body using the bonding member;
A method for producing a medical guide wire, comprising: forming a leading plug in which the core wire and an end of the coil spring body are joined using the joining member.

可とう性細長体から成る芯線と、前記芯線の先端部に前記芯線を貫挿したコイルスプリング体を装着し、前記芯線と前記コイルスプリング体との先端端部に接合部材を用いて先導栓を形成した医療用ガイドワイヤにおいて、
前記芯線が固溶化処理したオーステナイト系ステンレス鋼線を用いて、
伸線工程と前記伸線工程後に４００℃〜４９５℃で１０分から１８０分の低温熱処理工程を設けて、
前記伸線工程と前記低温熱処理工程を１セットとして少なくとも１セット以上各工程を繰り返した後に最終伸線工程を設けて、
前記最終伸線工程までの総減面率を９０％から９７．６％とし、
その後前記芯線に電気抵抗加熱による３８０℃〜４９５℃で３０秒から６０分の低温熱処理下で、
前記芯線の一端に捻回加工前の芯線の引張破断力の５％から３０％の負荷荷重を加えた状態で、他端を１００回／ｍから２７５回／ｍの捻回加工工程を設け、
その後４００℃〜４９５℃で１０分から１８０分の低温熱処理工程を設けて、
その後前記芯線先端部を研削加工、又は研削加工後に押圧加工する工程と、
前記芯線の先端部に前記芯線を貫挿してコイルスプリング体を装着する工程と、
前記接合部材を用いて前記芯線と前記コイルスプリング体とを部分的に接合させる工程と、
前記接合部材を用いて前記芯線と前記コイルスプリング体の端部とを接合させた先導栓を形成する工程とから成ることを特徴とする医療用ガイドワイヤの製造方法。 A core wire made of a flexible elongated body, a coil spring body having the core wire inserted through the distal end portion of the core wire, and a leading plug using a joining member at the distal end ends of the core wire and the coil spring body In the formed medical guidewire,
Using the austenitic stainless steel wire in which the core wire is subjected to solution treatment,
After the wire drawing step and the wire drawing step, a low temperature heat treatment step is performed at 400 ° C. to 495 ° C. for 10 minutes to 180 minutes,
The wire drawing step and the low temperature heat treatment step are set as one set, and after each step is repeated at least one set, a final wire drawing step is provided.
The total area reduction until the final wire drawing step is 90% to 97.6%,
Thereafter, the core wire is subjected to low-temperature heat treatment at 380 ° C. to 495 ° C. by electric resistance heating for 30 seconds to 60 minutes,
In the state where a load of 5% to 30% of the tensile breaking force of the core wire before twisting is applied to one end of the core wire, the other end is provided with a twisting process of 100 times / m to 275 times / m,
After that, a low temperature heat treatment step is performed at 400 to 495 ° C. for 10 to 180 minutes,
Then, the step of pressing the core wire tip after grinding or grinding,
Attaching the coil spring body by inserting the core wire through the tip of the core wire;
A step of partially bonding the core wire and the coil spring body using the bonding member;
A method of manufacturing a medical guide wire, comprising: forming a leading plug in which the core wire and an end of the coil spring body are joined using the joining member.

可とう性細長体から成る芯線と、前記芯線の先端部に前記芯線を貫挿したコイルスプリング体を装着し、前記芯線と前記コイルスプリング体との先端端部に接合部材を用いて先導栓を形成して、少なくとも前記芯線手元部の外周部に樹脂被膜を形成した医療用ガイドワイヤにおいて、
前記芯線が固溶化処理したオーステナイト系ステンレス鋼線を用いて、伸線工程と前記伸線工程後に４００℃〜４９５℃で１０分から１８０分の低温熱処理工程を設けて、
前記伸線工程と前記低温熱処理工程を１セットとして少なくとも１セット以上各工程を繰り返した後に最終伸線工程を設けて、
前記最終伸線工程までの総減面率を９０％から９７．６％とし、
その後前記芯線に電気抵抗加熱による３８０℃〜４９５℃で３０秒から６０分の低温熱処理下で、
前記芯線の一端に捻回加工前の芯線の引張破断力の５％から３０％の負荷荷重を加えた状態で、他端を１００回／ｍから２７５回／ｍの捻回加工工程を設け、
前記芯線先端部を研削加工、又は研削加工後に押圧加工する工程と、
前記芯線の少なくとも手元部に樹脂被膜を成形する工程と、
その後少なくとも前記芯線先端部を研削加工、又は研削加工後の押圧加工部分に
３４０℃〜４２０℃で１０分から１８０分の低温熱処理工程を設け、
前記芯線を貫挿してコイルスプリング体を装着する工程と、
前記接合部材を用いて前記芯線と前記コイルスプリング体とを部分的に接合させる工程と、
前記接合部材を用いて前記芯線と前記コイルスプリング体の端部とを接合させた先導栓を形成する工程とから成ることを特徴とする医療用ガイドワイヤの製造方法。 A core wire made of a flexible elongated body, a coil spring body having the core wire inserted through the distal end portion of the core wire, and a leading plug using a joining member at the distal end ends of the core wire and the coil spring body In a medical guide wire formed and formed with a resin coating on at least the outer peripheral portion of the core wire proximal portion,
Using the austenitic stainless steel wire in which the core wire is subjected to a solution treatment, a low-temperature heat treatment step is performed at 400 to 495 ° C. for 10 minutes to 180 minutes after the wire drawing step and the wire drawing step,
The wire drawing step and the low temperature heat treatment step are set as one set, and after each step is repeated at least one set, a final wire drawing step is provided.
The total area reduction until the final wire drawing step is 90% to 97.6%,
Thereafter, the core wire is subjected to low-temperature heat treatment at 380 ° C. to 495 ° C. by electric resistance heating for 30 seconds to 60 minutes,
In the state where a load of 5% to 30% of the tensile breaking force of the core wire before twisting is applied to one end of the core wire, the other end is provided with a twisting process of 100 times / m to 275 times / m,
Grinding the core wire tip, or pressing after grinding, and
Forming a resin film on at least the proximal portion of the core wire;
Thereafter, at least the tip end of the core wire is subjected to a grinding process, or a pressing process part after the grinding process is provided with a low temperature heat treatment step from 340 ° C. to 420 ° C. for 10 minutes to 180 minutes,
Inserting the coil spring body through the core wire; and
A step of partially bonding the core wire and the coil spring body using the bonding member;
A method of manufacturing a medical guide wire, comprising: forming a leading plug in which the core wire and an end of the coil spring body are joined using the joining member.

請求項６〜８のいずれか一つに記載の医療用ガイドワイヤの製造方法において、
前記芯線に電気抵抗加熱による３８０℃〜４９５℃で３０秒から６０分の低温熱処理下での捻回加工工程が、
前記最終伸線工程後に、前記芯線の一端に捻回加工前の芯線の引張破断力の５％から３０％の負荷荷重を加えた状態で、他端を１００回／ｍから２７５回／ｍの捻回加工を行い、
前記捻回加工の捻回数の増大に伴って前記芯線に電気抵抗加熱により徐変昇温させて、３８０℃〜４９５℃を最高温度とする低温熱処理下での捻回加工工程としたことを特徴とする医療用ガイドワイヤの製造方法。 In the manufacturing method of the medical guidewire as described in any one of Claims 6-8,
A twisting process under low temperature heat treatment for 30 seconds to 60 minutes at 380 ° C. to 495 ° C. by electric resistance heating to the core wire,
After the final wire drawing step, the other end of the core wire is 100 times / m to 275 times / m in a state where a load of 5% to 30% of the tensile breaking force of the core wire before twisting is applied to one end of the core wire. Twist processing,
With the increase in the number of twists in the twisting process, the core wire is gradually changed in temperature by electric resistance heating, and the twisting process is performed under a low-temperature heat treatment at a maximum temperature of 380 ° C to 495 ° C. A method for producing a medical guide wire.

請求項６〜９のいずれか一つに記載の医療用ガイドワイヤの製造方法において、
前記芯線の他端の捻回数が１００回／ｍから２００回／ｍの捻回加工工程としたことを特徴とする医療用ガイドワイヤの製造方法。 In the manufacturing method of the medical guidewire as described in any one of Claims 6-9,
A medical guide wire manufacturing method, characterized in that the twisting process of the other end of the core wire is performed at a twisting process of 100 times / m to 200 times / m.

請求項６〜１０のいずれか一つに記載の医療用ガイドワイヤの製造方法において、
前記接合部材を用いて前記芯線と前記コイルスプリング体とを接合させた後に、
前記コイルスプリング体外周部に樹脂被膜を成形し、その樹脂被膜成形時の熱を利用して、少なくとも前記コイルスプリング体内の前記芯線先端部に１８０℃〜３００℃で１０秒から６０分の低温熱処理工程を設けたことを特徴とする医療用ガイドワイヤの製造方法。 In the manufacturing method of the medical guidewire as described in any one of Claims 6-10,
After joining the core wire and the coil spring body using the joining member,
A resin coating is formed on the outer peripheral portion of the coil spring body, and heat at the time of molding the resin coating is used, and at least a tip end portion of the core wire in the coil spring body is heated at 180 ° C. to 300 ° C. for 10 seconds to 60 minutes. A method for producing a medical guide wire, comprising a step.

前記接合部材が１８０℃〜４９５℃の溶融温度をもつ共晶合金から成ることを特徴とする請求項１〜５のいずれか一つに記載の医療用ガイドワイヤ。 The medical guide wire according to any one of claims 1 to 5, wherein the joining member is made of a eutectic alloy having a melting temperature of 180 ° C to 495 ° C.

前記接合部材が１８０℃〜４９５℃の溶融温度をもつ共晶合金から成ることを特徴とする請求項６〜１１のいずれか一つに記載の医療用ガイドワイヤの製造方法。 The method for manufacturing a medical guide wire according to any one of claims 6 to 11, wherein the joining member is made of a eutectic alloy having a melting temperature of 180 ° C to 495 ° C.

請求項１〜５、１２のいずれか一つに記載の医療用ガイドワイヤと、マイクロカテーテルと、ガイディングカテーテルとの組立体において、
前記医療用ガイドワイヤの外径が０．２２８ｍｍから０．２５４ｍｍ（０．００９インチから０．０１０インチ）で、前記医療用ガイドワイヤを内径が０．２８ｍｍから０．９０ｍｍのマイクロカテーテル内へ挿入し、かつ、内径が１．５９ｍｍから２．００ｍｍのガイディングカテーテル内へ前記医療用ガイドワイヤと前記マイクロカテーテルが挿入されていることを特徴とする医療用ガイドワイヤとマイクロカテーテルとガイディングカテーテルとの組立体。 In the assembly of the medical guidewire according to any one of claims 1 to 5 and 12, a microcatheter, and a guiding catheter,
The medical guide wire is inserted into a microcatheter having an outer diameter of 0.228 mm to 0.254 mm (0.009 inch to 0.010 inch) and an inner diameter of 0.28 mm to 0.90 mm. And the medical guidewire, the microcatheter, and the guiding catheter, wherein the medical guidewire and the microcatheter are inserted into a guiding catheter having an inner diameter of 1.59 mm to 2.00 mm. Assembly.

請求項１〜５、１２のいずれか一つに記載の医療用ガイドワイヤと、バルーンカテーテルと、ガイディングカテーテルとの組立体において、
前記医療用ガイドワイヤの外径が０．２２８ｍｍから０．２５４ｍｍ（０．００９インチから０．０１０インチ）で、前記医療用ガイドワイヤを内径が０．２８ｍｍから０．９０ｍｍの前記バルーンカテーテル内へ挿入し、かつ、内径が１．５９ｍｍから２．００ｍｍの前記ガイディングカテーテル内へ、前記医療用ガイドワイヤと前記バルーンカテーテルが挿入されていることを特徴とする医療用ガイドワイヤとバルーンカテーテルとガイディングカテーテルとの組立体。 In the assembly of the medical guidewire according to any one of claims 1 to 5 and 12, a balloon catheter, and a guiding catheter,
The medical guide wire has an outer diameter of 0.228 mm to 0.254 mm (0.009 inch to 0.010 inch) and the medical guide wire is inserted into the balloon catheter having an inner diameter of 0.28 mm to 0.90 mm. The medical guide wire, the balloon catheter, and the guide are inserted into the guiding catheter having an inner diameter of 1.59 mm to 2.00 mm. Assembly with ding catheter.